Chat GPT vs New Bing (Microsoft), comparing responses to the same questions

Last updated: 11 May 2023

See updates at the end of the post.

In December 2022, I wrote a blog post on the chatbot, ChatGPT. So much has happened since then. There has been an explosion of articles and video clips on the internet, not just on ChatGPT but on other similar chatbots that are in the pipeline, including Bard from Google and Ernie from the Chinese search engine, Baidu. In this post, I have attempted to compare responses to the same questions from ChatGPT vs New Bing (Microsoft). Note that at the time of writing this post, New Bing (Microsoft) was not yet available to everyone but you had to join join a waiting list for access. Recently, Microsoft has opened it up to all users without a waitlist, as long as they’re signed into the search engine via Microsoft’s Edge browser.

What is New Bing (Microsoft)?

On 7 February 2023, Microsoft announced a new version of its search engine Bing (called New Bing), which incorporates the latest in artificial intelligence. It deploys OpenAI’s GPT technology.

If New Bing (Microsoft) incorporates GPT, why then is there a need to compare it with ChatGPT?

Reading various articles on the internet, it seems reasonably clear that ChatGPT is not identical to New Bing (Microsoft). An article on ZDNET states the following:

Microsoft said that the next-gen large language model (LLM) powering the New Bing is faster, more accurate, and “more capable” than ChatGPT or GPT-3.5, the LLM behind ChatGPT. The biggest difference is that Bing’s AI chatbot has access to the internet and ChatGPT does not.

Comparing ChatGPT vs ChatGPT vs New Bing (Microsoft)

In my original post, I shared the ten regulatory questions (and answers) that I asked ChatGPT. On 25 February 2023, I was granted access to New Bing (Microsoft). I thought it would be an idea to ask the identical questions that I had asked ChatGPT, to New Bing (Microsoft) and to tabulate the responses in a comparison table. As I was about to do this, another question popped up in my mind. If I ask the same ten questions that I asked ChatGPT originally, again, will I get the exact same answers?

You can see the answers to the questions in the table at the end of this post. I shall leave it to you the reader to ponder over whether the response to each question is correct/incorrect/partially correct, based on your regulatory knowledge.

Does ChatGPT give the same answer to the same question when it is asked on two separate occasions that are weeks or months apart?

Unsurprisingly, the answer to the same questions were different on both occasions. This is not unexpected as one would expect the chatbot to evolve the extent that it would refine its answers over time. What is surprising is just how different the answers are.
When I asked Q1. How is CAR-T Cell therapy regulated in the European Union? on 25 Feb 2023 and then again on 27 Feb 2023, the answers were different (see table below)
It seems not unreasonable to say that potentially, you can expect the answer to the same question to be unidentical each time irrespective of the time gap between asking the question first and then again and again. This does not mean to say that the answer will be entirely different on all occasions.

Is the ChatGPT response to the same question necessarily always better (i.e. correct, more accurate or better presented) on second asking of the same question?

I am not entirely convinced that the response is always better (i.e. correct, more accurate or better presented) on second asking of the same question . For example:

In response to Q5 I wish to licence a cancer medicine in the USA. Which licensing route is most appropriate?, ‘fast-track designation’ was mentioned in the first response but not in the second.
When Q7. I wish to licence a generic medicine in the UK. What data must I submit to the MHRA? was asked second time, the response states that ‘non-clinical data’ and ‘clinical data’ should be submitted. For generic applications, you would normally refer to the non-clinical and clinical data as obtained for the reference product. Additionally, in the response, ‘Pharmaceutical data’ are separated out from ‘Quality data’. Note also that the response to the same question on both occasions is quite different.

How do responses to the same question compare between ChatGPT and New Bing (Microsoft)?

In response to this question, I have shared my thoughts (and these are not necessarily right or wrong or better in any way than you the reader or anyone else might think) under various headings below:

i) Identicality of responses / better or worse responses

The responses from ChatGPT and New Bing (Microcoft) are neither identical nor are they necessarily always better or worse (if better could be described as correct, more accurate or better presented).

ii) Referencing of responses

The first thing that you cannot help but notice about the New Bing (Microsoft) responses is that they are referenced, so it is quite easy to determine where a particular sentence in a response has come from. Oddly, the number of references listed at the end of a response don’t always seem to match the actual number of references used in a response For example, if we consider the response to Q1. How is CAR-T Cell therapy regulated in the European Union?, note that there are only four references (1,2,3 and 4) in the body of the response, but the bot lists 5 references at the end of the response and so on.
It is very useful to have referenced answers not least because it gives on the opportunity to decide whether the source(s) of information for a response are trustworthy.

Note that ChatGPT does not currently reference its answers and so it is not possible to establish the origin of its responses.

iii) Delivery of responses

Unlike Chat GPT, it seems that New Bing (Microsoft) does not deliver a full answer to a question all at once. Note at the end of an answer to a question, there is often another question (these questions are highlighted in BLUE in the third column of the table at the end of this post). For example at the end of the answer to Q4. What licensing routes are available in the European Union to licence medicines?, there is the question Which route are you interested in? . The further choices that you are presented with on the screen are:
- centralised route,
- the national route,
- both routes
I clicked on the option ‘both routes’ and got a follow up answer, with the follow up question What kind of medicine are you interested in?
The above repeats each time you ask New Bing (Microsoft) a question so it seems that a an answer is delivered piecemeal by asking an initial question and then asking further question(s). Arguably, this might deliver a better overall response.

iv) Does it matter what you ask and how you ask it?

I think it does matter. As I look a my questions, the wording is not quite as precise as I would like it to have been. Any vagueness, imprecision or unintended use of words in a question has the potential to have an impact (be it substantial or otherwise) on the answer.

So what does all of this mean as far as using ChatGPT/other chatbot/search engine incorporating AI to answer regulatory questions is concerned?

As things stand currently, based on the responses that I have seen from ChatGPT and/or New Bing (Microsoft) it seems to me that using ChatGPT/other chatbot/search engine incorporating AI as the sole way to answer a regulatory question may not be the best option.

One option might be to use ChatGPT/other chatbot/search engine incorporating AI, as a starting point to ask a regulatory question. The answer obtained could be used to do further research in order to establish whether it is correct or to obtain the correct answer.

Remember that what you ask and how you ask is quite likely to impact the answer.

The table below details the answers to the questions, as obtained from ChatGPT and New Bing (Microsoft).

Q1. How is CAR-T Cell therapy regulated in the European Union?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023	Notes/Comments
CAR-T cell therapy is regulated by the European Medicines Agency (EMA), which is the regulatory body responsible for evaluating and approving medicinal products in the European Union (EU). In order to be approved for use in the EU, CAR-T cell therapy must undergo a thorough evaluation process to ensure its safety, efficacy, and quality. This process typically involves pre-clinical studies, clinical trials, and a detailed review of the product’s manufacturing processes. Once a CAR-T cell therapy has been approved by the EMA, it can be used in the EU for the treatment of certain diseases.	CAR-T cell therapy is regulated in the European Union (EU) as an advanced therapy medicinal product (ATMP) under Regulation (EC) No. 1394/2007. This regulation provides a regulatory framework for the development, evaluation, authorization, and post-authorization monitoring of advanced therapies, including CAR-T cell therapy. CAR-T cell therapy is considered a gene therapy product, which is defined as a biological medicinal product that contains genetic material that has been manipulated in vitro. As such, CAR-T cell therapy is subject to specific regulatory requirements in the EU, including the need for clinical trials to demonstrate safety and efficacy before it can be authorized for use. The European Medicines Agency (EMA) is the regulatory body responsible for evaluating and authorizing CAR-T cell therapies in the EU. The EMA’s Committee for Advanced Therapies (CAT) provides scientific advice on the development of advanced therapies, including CAR-T cell therapies, and assesses applications for marketing authorization. The EMA’s evaluation process for CAR-T cell therapies involves a comprehensive review of the product’s quality, safety, and efficacy data. The evaluation also includes an assessment of the manufacturing process, as CAR-T cell therapies are highly personalized and require a complex manufacturing process. Once a CAR-T cell therapy has been authorized by the EMA, it is subject to post-authorization monitoring to ensure its continued safety and efficacy. This monitoring includes ongoing clinical studies, pharmacovigilance activities, and risk management measures. In summary, CAR-T cell therapy is regulated in the European Union as an advanced therapy medicinal product, and its development, evaluation, authorization, and post-authorization monitoring are overseen by the EMA’s Committee for Advanced Therapies.	CAR-T Cell therapy is a type of advanced therapy medicinal product (ATMP) and gene therapy medicinal product (GTMP) that uses modified immune cells to treat cancer^{1 2}. CAR-T Cell therapy is regulated by the European Medicines Agency (EMA), which evaluates and approves its marketing authorisation in the European Union (EU)^{3 1}. The EMA also provides scientific advice and support for developers of CAR-T Cell therapies through its PRIME scheme^{3 2}. As of now, there are two CAR-T Cell therapies approved by the EMA: Kymriah and Yescarta^{3 4}. They are used to treat certain types of blood cancer^{3 4}. Is there anything else you would like to know? Learn more: 1. labiotech.eu 2. ehaweb.org 3. ema.europa.eu 4. ema.europa.eu 5. europarl.europa.eu	Below is the ChatGPT response to the same question on 27 Feb 2023. CAR-T cell therapy is regulated in the European Union (EU) as an advanced therapy medicinal product (ATMP). ATMPs are products that are based on genes, tissues, or cells and are used for therapeutic purposes. As a result, they are subject to special regulations and requirements for clinical trials, authorization, and post-marketing surveillance. The European Medicines Agency (EMA) is responsible for the regulation and approval of ATMPs, including CAR-T cell therapy, in the EU. The regulatory process for CAR-T cell therapy in the EU is similar to that of other medicinal products, but there are additional requirements specific to ATMPs. The process involves several steps, including preclinical testing, clinical trials, and marketing authorization. The preclinical testing phase involves laboratory testing and animal studies to assess the safety and efficacy of the CAR-T cell therapy. If the results are positive, the therapy can move on to clinical trials, which involve testing in humans. Clinical trials are conducted in several phases, with increasing numbers of participants and longer follow-up periods to assess safety and efficacy. Once the clinical trials are completed, the manufacturer of the CAR-T cell therapy can apply for marketing authorization from the EMA. The EMA evaluates the application and assesses the benefits and risks of the therapy. If the therapy is approved, it can be marketed and sold in the EU. After approval, the EMA continues to monitor the safety and efficacy of the CAR-T cell therapy through post-marketing surveillance. This involves ongoing data collection and analysis to detect any adverse effects or other issues that may arise with the therapy. Overall, CAR-T cell therapy is subject to strict regulations and requirements in the EU to ensure that it is safe and effective for patients. The process for approval and monitoring is designed to ensure that patients receive the best possible treatment while minimizing any potential risks. ——– Note that the New Bing (Microsoft) responses are referenced, so it is quite easy to determine where a particular sentence in a response has come from. Oddly, the number of references listed at the end of a response don’t always seem to match the actual number of references used in a response. note that there are only four references (1,2,3 and 4) in the body of the response, but the bot lists 5 references at the end of the response
2. How long does it take to licence a biological product in the US?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
The amount of time it takes to license a biological product in the US can vary depending on a number of factors, including the complexity of the product and the completeness of the submission made to the FDA. On average, the biologics licensing process can take several years to complete. It typically involves pre-clinical studies, clinical trials, and a detailed review of the product’s manufacturing processes. Once a biological product has been licensed by the FDA, it can be marketed and sold in the US.	The time it takes to license a biological product in the United States can vary depending on a variety of factors, including the complexity of the product and the regulatory pathway being used for approval. Biological products in the US are regulated by the Food and Drug Administration (FDA) under the Public Health Service Act. The FDA has several regulatory pathways for approving biological products, including: 1. Biologics License Application (BLA) pathway: This pathway is used for the approval of new biologic products, such as monoclonal antibodies or gene therapies. The timeline for approval of a BLA can range from several months to several years, depending on the complexity of the product and the results of clinical trials. 2. Biosimilar pathway: This pathway is used for the approval of products that are highly similar to an already approved biological product. The timeline for approval of a biosimilar can be shorter than that of a BLA, as some data from the reference product can be used to support the application. 3. Interchangeability pathway: This pathway is used for the approval of biosimilars that have been shown to be interchangeable with the reference product, meaning they can be substituted for the reference product without the involvement of the prescriber. This pathway requires additional data and can take longer than the biosimilar pathway. Overall, the approval process for a biological product in the US typically involves preclinical studies, clinical trials, and regulatory review by the FDA. The length of time it takes to license a biological product can vary widely, depending on the complexity of the product, the results of clinical trials, and the regulatory pathway being used for approval.	A biological product is a substance derived from a living organism that is used to prevent, treat, or cure disease¹. To license a biological product in the US, the manufacturer must submit a Biologics License Application (BLA) to the FDA^{1 2}. The BLA must include data from nonclinical and clinical studies that show the product’s safety, purity, and potency^{2 3}. The FDA reviews the BLA and decides whether to approve or reject it within 10 months of filing¹. The approval process may vary depending on the type and complexity of the biological product¹. What are you interested in learning more about? Learn more: 1. fda.gov 2. law.cornell.edu 3. law.cornell.edu 4. fda.gov
Q3. I wish to market a medical device in the European Union. What route of authorisation must I follow?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
In order to market a medical device in the European Union (EU), you must follow the EU’s medical device regulatory framework. This framework is designed to ensure the safety and efficacy of medical devices in the EU. Under this framework, medical devices are classified into four classes based on the level of risk they pose to patients. Class I devices are considered low-risk and can typically be placed on the market without undergoing a specific conformity assessment procedure. Class IIa, IIb, and III devices are considered to pose a higher level of risk and must undergo a conformity assessment procedure before they can be placed on the market. The conformity assessment procedure for medical devices typically involves a review of the product’s technical documentation and a conformity assessment by a notified body. Once a medical device has been assessed and certified by a notified body, it can be placed on the market in the EU.	If you wish to market a medical device in the European Union (EU), you must follow the requirements of the EU Medical Devices Regulation (MDR) or the EU In Vitro Diagnostic Regulation (IVDR), depending on the type of device. Medical devices are divided into four risk classes: I, IIa, IIb, and III. In general, the higher the risk, the more rigorous the conformity assessment procedure required. For low-risk devices (Class I), the manufacturer must prepare a Declaration of Conformity and affix the CE mark to the device, indicating that it meets the requirements of the MDR or IVDR. For medium-risk devices (Class IIa and IIb), the manufacturer must also have their quality management system assessed by a Notified Body. This assessment includes a review of technical documentation, an on-site audit, and ongoing surveillance. For high-risk devices (Class III), the manufacturer must also have a clinical evaluation report and conduct a post-market clinical follow-up study. The manufacturer must also have their quality management system assessed by a Notified Body, and the conformity assessment process is more rigorous than for lower-risk devices. In addition, the manufacturer must designate a “person responsible for regulatory compliance” (PRRC) who is responsible for ensuring that the device meets the requirements of the MDR or IVDR. In summary, the route of authorization you must follow to market a medical device in the EU depends on the risk classification of the device. Generally, for low-risk devices, a Declaration of Conformity and CE marking are sufficient. For higher-risk devices, a Notified Body assessment, clinical evaluation, and post-market surveillance are required. It is important to consult with a regulatory expert to ensure compliance with the MDR or IVDR requirements.	To market a medical device in the European Union (EU), you must follow the Medical Device Regulation (MDR) that applies since 26 May 2021^{1 2}. The MDR requires you to demonstrate that your medical device meets legal requirements for safety and performance^{1 2}. Depending on the type and risk class of your medical device, you may need to undergo a conformity assessment by a notified body^{1 2}. You also need to register your medical device and yourself as a manufacturer in EUDAMED, the EU database for medical devices^{1 2}. What kind of medical device do you wish to market? Learn more: 1. ema.europa.eu 2. eumdr.com 3. eumdr.com 4. ema.europa.eu
Q4. What licensing routes are available in the European Union to licence medicines?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
In the European Union (EU), there are several routes available for licensing medicines. The most common route is through the European Medicines Agency (EMA), which is the centralized regulatory body responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The EMA offers a centralized marketing authorization procedure, which allows a single application to be submitted for approval of a medicine in all EU member states. This streamlined process can save time and resources for pharmaceutical companies, and it also ensures that medicines are approved to the same high standards across the EU. In addition to the centralized procedure, there are also national procedures for licensing medicines in individual EU member states. This may be necessary if a medicine is intended for use in a specific country or if it is not eligible for evaluation through the centralized procedure. Finally, there is also the option of obtaining a mutual recognition procedure (MRP), which allows a medicine that has already been authorized in one EU member state to be recognized and approved in other member states. This can speed up the approval process and make it easier for patients to access medicines that have already been proven safe and effective. Overall, the EU offers a range of options for licensing medicines, and the specific route that a pharmaceutical company chooses will depend on the specific circumstances of the medicine being developed.	There are several licensing routes available in the European Union (EU) to license medicines, depending on the type of medicine and its intended use. The main licensing routes are: 1. Centralized procedure: This is the mandatory route for certain types of medicines, such as those intended for the treatment of AIDS, cancer, diabetes, and neurodegenerative diseases. The centralized procedure involves a single application to the European Medicines Agency (EMA) for marketing authorization that is valid in all EU member states, and the evaluation is performed by the EMA’s Committee for Medicinal Products for Human Use (CHMP). 2. Decentralized procedure: This is the route for medicines that are not eligible for the centralized procedure, but for which the applicant wishes to market the product in more than one EU member state. The decentralized procedure involves simultaneous applications to multiple national regulatory authorities, with one authority acting as the “reference member state” and coordinating the evaluation process. 3. Mutual recognition procedure: This is the route for medicines that have already been authorized in one EU member state and the applicant wishes to market the product in another member state. The mutual recognition procedure involves the submission of an application to the regulatory authority of the member state where the product is to be marketed, with the previously authorized member state acting as the “reference member state.” 4. National procedure: This is the route for medicines that are intended to be marketed in only one EU member state. The national procedure involves the submission of an application to the regulatory authority of the member state where the product is to be marketed. In addition, there is also a simplified procedure called the “authorization under exceptional circumstances” for medicines that treat rare diseases or conditions, where the applicant can rely on less comprehensive data to support the application. Overall, the licensing route chosen depends on the type of medicine, its intended use, and the scope of the marketing authorization. It is important to consult with a regulatory expert to determine the most appropriate licensing route for a specific medicine.	Hello, this is Bing. According to ¹, there are two main routes for authorising medicines in the EU: a centralised route and a national route. The centralised route involves applying for a single marketing authorisation that is valid across the EU, while the national route involves applying for one or more national marketing authorisations that are valid only in specific countries^{1 2}. Which route are you interested in? (Choice of routes given, to click on are 1) centralised route, 2) the national route, 3) both routes) Learn more: 1. ema.europa.eu 2. ema.europa.eu 3. legislation.gov.uk 4. ema.europa.eu 5. ema.europa.eu From the choice of routes given above, if you click on Option 3) both routes, you get the following answer: I see. Here are some brief differences between the two routes: The centralised route allows you to apply for a single marketing authorisation that is valid across all EU countries, as well as Iceland, Norway and Liechtenstein^{1 2 3}. This route is mandatory for certain types of medicines, such as those for rare diseases, cancer, HIV/AIDS and biotechnology products^{1 2}. The national route allows you to apply for one or more national marketing authorisations that are valid only in specific countries^{1 2}. This route is mainly used for generic medicines, traditional herbal medicines and homeopathic products⁴. You can also use this route to apply for a marketing authorisation in one country first, and then seek mutual recognition from other countries later⁴. What kind of medicine are you interested in? Learn more: 1.drugregulatoryintelligence.home.blog 2.drugregulatoryintelligence.home.blog 3. ema.europa.eu 4. hma.eu 5. ema.europa.eu
Q5. I wish to licence a cancer medicine in the USA. Which licensing route is most appropriate?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023	Notes
In the United States, the licensing of cancer medicines is handled by the Food and Drug Administration (FDA). The FDA is the federal agency responsible for regulating the safety and effectiveness of drugs, medical devices, and other products in the US. The most appropriate licensing route for a cancer medicine in the US will depend on the specific circumstances of the medicine, including its intended use, the stage of development, and the type of cancer it is intended to treat. In general, however, the FDA offers several different pathways for the approval of cancer drugs, including the following: · Fast Track designation: This is a program that allows the FDA to expedite the review of drugs that have the potential to treat a serious or life-threatening condition. This can help accelerate the development and review of cancer drugs that are intended to treat serious or life-threatening conditions. · Breakthrough Therapy designation: This is a program that allows the FDA to expedite the development and review of drugs that show early clinical evidence of substantial improvement over existing therapies. This can help accelerate the development and review of cancer drugs that show promising early results. · Accelerated Approval: This is a program that allows the FDA to approve drugs based on surrogate endpoints (i.e., measures that are not necessarily indicative of clinical benefit) when the drug is intended to treat a serious or life-threatening condition and there is a demonstrated improvement over existing therapies. · Priority Review: This is a program that allows the FDA to expedite the review of drugs that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This can help accelerate the review of cancer drugs that are intended to treat serious or life-threatening conditions. Overall, the FDA offers a range of options for the approval of cancer drugs, and the specific route that a pharmaceutical company chooses will depend on the specific circumstances of the drug being developed. It is important to consult with the FDA early in the development process to determine the most appropriate pathway for approval.	If you wish to license a cancer medicine in the United States, the most appropriate licensing route depends on several factors, such as the type of cancer medicine and the stage of development. The most common licensing routes for cancer medicines in the US are: 1. New Drug Application (NDA): This is the route for cancer medicines that have never been approved by the US Food and Drug Administration (FDA). The NDA requires extensive clinical trial data to demonstrate the safety and efficacy of the medicine, and the review process can take several months to years. 2. Biologics License Application (BLA): This is the route for cancer medicines that are classified as biologics, such as monoclonal antibodies or gene therapies. The BLA process is similar to the NDA process, requiring extensive clinical trial data and regulatory review. 3. Accelerated Approval: This is a pathway for cancer medicines that treat serious or life-threatening diseases and provide a meaningful therapeutic benefit over existing treatments, based on surrogate endpoints. The approval is granted on the condition that the manufacturer conducts post-approval studies to confirm the benefit of the medicine. 4. Breakthrough Therapy Designation: This is a designation granted by the FDA for cancer medicines that show significant improvement over existing therapies in early clinical trials. The designation provides increased communication and collaboration with the FDA, and the manufacturer may be eligible for expedited review. 5. Orphan Drug Designation: This is a designation granted by the FDA for cancer medicines that treat rare diseases, defined as affecting fewer than 200,000 people in the US. The designation provides tax incentives, fee waivers, and marketing exclusivity. Overall, the most appropriate licensing route for a cancer medicine in the US depends on the specific characteristics of the medicine and its intended use. It is important to consult with a regulatory expert to determine the most appropriate pathway and to ensure compliance with FDA requirements.	There are different ways to license a cancer medicine in the USA, depending on the type of cancer, the stage of development, and the availability of existing treatments. One possible option is to apply for accelerated approval from the Food and Drug Administration (FDA) based on surrogate endpoints that are reasonably likely to predict clinical benefit¹. Another possible option is to enter into a voluntary licensing agreement with another company or organization that has access to a patented cancer medicine². This can help expand access to low- and middle-income countries where there is a high unmet need for affordable cancer treatments². What type of cancer medicine do you wish to license? Learn more: 1. lse.ac.uk 2. uicc.org 3. cancerresearchuk.org 4. cancer.gov	Fast-track designation is mentioned in the first response from ChatGPT but not in the second response of 27 Feb 2023.
Q6. What are the different stages of drug product registration in Mexico?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
The stages of drug product registration in Mexico typically include the following: 1. Pre-registration: This is the first stage of the registration process, during which the applicant submits a pre-registration application to the Mexican Ministry of Health. The pre-registration application should include information about the product, such as its composition, indications, and manufacturing process. 2. Technical review: In this stage, the Ministry of Health will review the pre-registration application to ensure that it meets all of the necessary technical requirements. This may include conducting laboratory testing to verify the quality and safety of the product. 3. Clinical trials: If the product is a new drug or medical device, it may be necessary to conduct clinical trials to demonstrate its safety and effectiveness. These trials must be conducted in accordance with Mexican regulations and must be approved by the Ministry of Health. 4. Registration: If the product passes the technical review and any required clinical trials, the Ministry of Health will issue a registration certificate for the product. This certificate will be valid for a certain period of time, after which it must be renewed. 5. Post-registration: After the product has been registered, the applicant must submit regular reports to the Ministry of Health to update them on the product’s safety and effectiveness. The Ministry of Health may also conduct periodic inspections of the product’s manufacturing facilities to ensure that they meet regulatory standards. It’s important to note that the exact registration process may vary depending on the specific type of product being registered and the specific requirements of the Ministry of Health. It’s recommended that you consult with a regulatory expert to ensure that you follow the correct registration process for your product.	The drug product registration process in Mexico involves several stages, which include: 1. Preclinical studies: Before a drug product can be tested on humans, preclinical studies are conducted to assess the safety and efficacy of the product in animal models. 2. Clinical trials: Once preclinical studies are completed, clinical trials are conducted to evaluate the safety and efficacy of the drug product in humans. Clinical trials in Mexico are required to comply with Good Clinical Practices (GCP) guidelines.1. 3. Submission of registration application: Once the clinical trials are completed, the drug product registration application is submitted to the Federal Commission for Protection against Health Risks (COFEPRIS) in Mexico. 4. Review and evaluation: COFEPRIS reviews the registration application to ensure compliance with Mexican regulations and guidelines. The review includes evaluation of the safety, efficacy, quality, and labeling of the drug product. 5. Approval and registration: If the drug product meets the requirements, COFEPRIS grants approval and registers the product for sale in Mexico. The registration process includes obtaining a Certificate of Free Sale and a Unique Product Key. 6. Post-registration surveillance: After the drug product is registered, COFEPRIS conducts post-registration surveillance to ensure compliance with regulations and guidelines. It is important to note that the drug product registration process in Mexico can be complex and may require the assistance of regulatory experts to navigate the process effectively.	According to ¹, drug registration in Mexico starts when a pharmaceutical company submits an application dossier to COFEPRIS, which is the regulatory authority for drugs in Mexico. The dossier must contain information on quality, safety and efficacy of the drug¹². Depending on whether the drug is a new molecule, a generic or an OTC product, there may be different requirements and procedures for registration^{2 3}. For example, new molecules must be approved by a New Molecules Committee before getting market authorization^{4 2}. Are you interested in registering a specific type of drug in Mexico? Learn more: 1. latampharmara.com 2.globalregulatorypartners.com 3. chameleon-pharma.com 4.globalregulatorypartners.com 5.globalregulatorypartners.com
Q7. I wish to licence a generic medicine in the UK. What data must I submit to the MHRA?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023	Notes
In the United Kingdom (UK), the licensing of generic medicinal products is carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). To obtain a license for a generic medicinal product in the UK, you will need to submit a marketing authorization application (MAA) to the MHRA. The MAA should include the following data and documentation: 1. A comprehensive description of the generic medicinal product, including its composition, formulation, and manufacturing process. 2. Clinical data, including data on the bioequivalence of the generic medicinal product to the reference medicinal product. 3. A summary of the product’s benefits and risks. 4. A risk management plan outlining the measures that will be taken to ensure the safe and effective use of the product. 5. Quality data, including data on the quality, safety, and efficacy of the generic medicinal product. 6. A statement of the product’s therapeutic equivalence to the reference medicinal product. 7. A certificate of suitability (CEP), which is a document issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) that attests to the quality of the active substance used in the generic medicinal product. 8. A declaration of the product’s compliance with good manufacturing practices (GMP). 9. A declaration of the product’s compliance with good clinical practices (GCP). 10. A declaration of the product’s compliance with good laboratory practices (GLP). 11. A declaration of the product’s compliance with good distribution practices (GDP).	To license a generic medicine in the UK, you must submit a Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA). The MAA should contain the following data: 1. Pharmaceutical data: The pharmaceutical data should include information on the composition and manufacturing process of the generic medicine, including the active ingredient(s), excipients, and dosage form. 2. Non-clinical data: The non-clinical data should include data on the pharmacology and toxicology of the generic medicine, as well as data on its safety and efficacy. 3. Clinical data: The clinical data should include data from bioequivalence studies that demonstrate that the generic medicine is equivalent to the reference product in terms of safety, efficacy, and quality. This may include data from in vivo or in vitro studies, depending on the product. 4. Quality data: The quality data should include information on the quality control and quality assurance systems in place to ensure the consistent quality of the generic medicine. 5. Labeling and product information: The labeling and product information should include information on the product’s uses, dosage, administration, contraindications, precautions, and adverse reactions. The MHRA will review the MAA to ensure that the generic medicine meets the requirements for safety, efficacy, and quality. The review process may involve further questions and clarification, and may take several months to complete. Once the generic medicine is approved, it will be granted a Marketing Authorization and can be marketed in the UK.	To market a generic medicine in the UK, you need a licence (marketing authorisation) issued by the Medicines and Healthcare products Regulatory Agency (MHRA)¹. You also need to comply with EU good manufacturing practice (GMP) and pass regular GMP inspections of your site². Are you planning to make, assemble or import your generic medicine? Learn more: 1. gov.uk 2. gov.uk 3.assets.publishing.service.gov.uk 4. gov.uk 5. gov.uk 6. gov.uk	The ChatGPT response on 27 Feb 2023 states that ‘non-clinical data’ and ‘clinical data’ should be submitted. For generic applications, you would normally refer to the non-clinical and clinical data as obtained for the reference product. Additionally, in the response, ‘Pharmaceutical data’ are separated out from ‘Quality data’. Note also that the response to the same question on both occasions is quite different.
Q8. Under the Clinical Trials Regulation (EU) No 536/2014, what documentation is required for the authorisation of a clinical trial?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
Under the Clinical Trials Regulation (EU) No 536/2014, the following documents are required for the authorization of a clinical trial: 1. A protocol: This is a detailed plan that outlines the objectives, design, methodology, statistical considerations, and organization of the clinical trial. It should also include information on the investigational medicinal product (IMP) and any relevant non-investigational medicinal products (NIMPs). 2. An investigator’s brochure: This is a document that provides detailed information on the IMP, including its composition, pharmacology, and toxicology. 3. A summary of the clinical trial protocol: This is a concise and easy-to-understand summary of the protocol that should be understandable to the general public. 4. A patient information sheet: This is a document that provides detailed information about the clinical trial to potential participants, including the purpose of the trial, the procedures involved, and any potential risks or benefits. 5. An informed consent form: This is a document that explains the clinical trial to potential participants and describes their rights and responsibilities as participants. It must be signed by the participant or their legally authorized representative before they can participate in the trial. 6. A statement of adherence to good clinical practice: This is a document that outlines the steps that will be taken to ensure that the clinical trial is conducted in accordance with good clinical practice (GCP) guidelines. 7. A statement of the arrangements for indemnification: This is a document that describes the arrangements that have been made to indemnify the sponsor, the investigator, and any other parties involved in the clinical trial in the event of any damages arising from the trial. 8. A statement of the arrangements for data protection: This is a document that describes the measures that will be taken to protect the personal data of the trial participants and to ensure that their privacy is respected. 9. A statement of the arrangements for liability insurance: This is a document that describes the arrangements that have been made to insure the sponsor, the investigator, and any other parties involved in the clinical trial against any potential liabilities arising from the trial. 10. Any other relevant documents: Depending on the specific circumstances of the clinical trial, additional documents may be required. For example, if the trial involves the use of a new medical device, additional documents related to the device may be required.	Under the Clinical Trials Regulation (EU) No 536/2014, the following documentation is required for the authorization of a clinical trial: 1. Clinical Trial Application (CTA): The CTA is the main document required for authorization of a clinical trial in the EU. It includes detailed information about the clinical trial, such as the objectives, study design, patient population, investigational medicinal product (IMP), and study procedures. 2. Investigator’s Brochure (IB): The IB is a document that provides comprehensive information about the IMP, including its pharmacological and toxicological properties, and clinical trial data from previous studies. 3. Ethics Committee (EC) Opinion: Before a clinical trial can begin, the study protocol and other study-related documents must be reviewed and approved by an independent ethics committee (EC) in the EU member state where the trial will be conducted. 4. Protocol and Protocol Amendments: The protocol describes the design, methodology, objectives, and statistical considerations of the clinical trial. Any amendments to the protocol must also be submitted for review and approval by the EC and the competent authorities. 5. Informed Consent Form (ICF): The ICF is a document that provides detailed information about the clinical trial to the study participants, including the risks and benefits of participation. Participants must provide informed consent before they can participate in the clinical trial. 6. Safety Reporting Plan (SRP): The SRP outlines the procedures for reporting and managing adverse events and serious adverse events that occur during the clinical trial. 7. Risk Management Plan (RMP): The RMP is a document that outlines the measures that will be taken to minimize and manage the risks associated with the IMP during the clinical trial. These documents are required to ensure that the clinical trial is conducted in accordance with ethical and regulatory standards, and that the safety and rights of the study participants are protected.	According to Regulation (EU) No 536/2014¹, a clinical trial application should include: · A cover letter · A protocol · An investigator’s brochure · A summary of product · characteristics · An informed consent form · A recruitment advertisement · A label for investigational medicinal products · A risk proportionate approach document · An insurance certificate These documents should be submitted via the Clinical Trials Information System (CTIS)^{2 3}, which is a single entry point for all clinical trials conducted in the EU. What kind of clinical trial are you interested in? Learn more: 1. eur-lex.europa.eu 2. health.ec.europa.eu 3. ema.europa.eu 4. arkivum.com 5. health.ec.europa.eu
Q9. What registration samples are required to register a pharmaceutical product in India?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
To register a pharmaceutical product in India, the following samples are generally required: 1. Representative samples of the finished product: These are samples of the actual product that will be sold to consumers, and should be representative of the batch that will be manufactured for commercial distribution. 2. Stability samples: These are samples of the finished product that have been specially prepared and stored under defined conditions to evaluate the product’s stability over time. 3. Raw material samples: These are samples of all the raw materials that will be used in the manufacture of the finished product. 4. Packaging material samples: These are samples of all the packaging materials that will be used to package the finished product. 5. In-process material samples: These are samples of materials that are intermediate products produced during the manufacturing process. 6. Laboratory control samples: These are samples of the finished product that are used to verify the accuracy of the laboratory control tests. 7. Process validation samples: These are samples of the finished product that are produced during process validation studies to ensure that the manufacturing process is consistently producing a product of the required quality.	To register a pharmaceutical product in India, the following registration samples are typically required: 1. Active Pharmaceutical Ingredient (API) samples: Two samples of the API used in the pharmaceutical product must be submitted to the Central Drugs Standard Control Organization (CDSCO) in India for testing. 2. Finished Product samples: Two to three samples of the finished product must be submitted to the CDSCO for testing. 3. Reference Listed Drug (RLD) samples: If the pharmaceutical product is a generic product, two samples of the RLD must be submitted to the CDSCO for comparative testing. 4. Stability samples: Stability studies are required to demonstrate the shelf life and stability of the pharmaceutical product. Samples from the stability studies must be submitted to the CDSCO for testing. 5. Microbiological samples: For certain types of pharmaceutical products, such as sterile products, microbiological samples must be submitted to the CDSCO for testing. 6. Packaging samples: Samples of the primary and secondary packaging materials must be submitted to the CDSCO for testing to ensure that they meet the required standards. It is important to note that the specific requirements for registration samples may vary depending on the type of pharmaceutical product being registered and the regulations in place at the time of registration. It is recommended to consult with a regulatory expert or the CDSCO for specific guidance on registration requirements.	According to web sources^{1 2}, you need to obtain a drug registration from the Central Drugs Standard Control Organization (CDSCO) within Ministry of Health and Family Welfare in India. The process and requirements may vary depending on whether you are importing or manufacturing your product, and whether it is a new drug or not². You may also need a drug sale license from your state authority¹. Are you importing or manufacturing your product? Is it a new drug? Learn more: 1. artixio.com 2. pacificbridgemedical.com 3. researchgate.net
Q10. Is there a way to easily find information on ongoing or recently completed pharmaceutical cases in the EU?
ChatGPT answer – Dec 2022/ Jan 2023	ChatGPT answer – 25 Feb 2023	New Bing (Microsoft) answer – 25 Feb 2023
Yes, there are several ways to find information on ongoing or recently completed pharmaceutical cases in the European Union (EU). Here are a few options: 1. European Medicines Agency (EMA) Website: The EMA maintains a website (www.ema.europa.eu) where you can find information on various aspects of pharmaceutical regulation in the EU, including information on ongoing and completed cases. 2. EU Health Portal: The EU Health Portal (https://ec.europa.eu/health/index_en) provides a wealth of information on EU health policy and related topics, including information on pharmaceutical regulation and cases. 3. EU Court of Justice: The EU Court of Justice (https://curia.europa.eu) is the highest court in the EU and makes decisions on a range of legal matters, including pharmaceutical cases. You can find information on recent and ongoing cases on the Court’s website. 4. EU Competition Authority: The EU Competition Authority (https://ec.europa.eu/competition/index_en.html) is responsible for enforcing EU competition law and can take action against companies that engage in anti-competitive behavior. The Authority’s website provides information on recent and ongoing cases, including those involving pharmaceutical companies.	Yes, there are a few resources available to find information on ongoing or recently completed pharmaceutical cases in the EU: 1. European Medicines Agency (EMA) – EudraCT database: The EMA maintains a publicly accessible clinical trials database called EudraCT, which contains information on ongoing and completed clinical trials conducted in the EU. The database can be searched by product name, active substance, sponsor, and other parameters. 2. European Medicines Agency (EMA) – Pharmacovigilance Database (EudraVigilance): EudraVigilance is a database of suspected adverse reactions to medicines that have been authorized in the EU. It can be used to search for information on ongoing or completed pharmacovigilance cases. 3. European Commission (EC) – EU Register of Authorized Medicinal Products: The EC maintains a database of authorized medicinal products in the EU, which can be searched by product name, active substance, and other parameters. The database also provides information on the status of the product, such as whether it is currently authorized or has been withdrawn from the market. 4. National regulatory authorities: National regulatory authorities in the EU member states also maintain databases and provide information on ongoing or completed pharmaceutical cases. These databases can be searched on a country-by-country basis and may provide additional information not available in the EMA databases. It is important to note that the availability and accessibility of information may vary depending on the case and the jurisdiction involved. It is recommended to consult with a regulatory expert or legal counsel for specific guidance on obtaining information on pharmaceutical cases in the EU.	Hello, this is Bing. I’m glad you asked. There are several sources that can help you find information on ongoing or recently completed pharmaceutical cases in the EU. One of them is the European Medicines Agency (EMA)¹, which is responsible for authorising and supervising medicinal products for human and veterinary use in the EU. Another source is the Pharmaceutical Strategy for Europe², which was adopted by the European Commission in November 2020 and aims to create a future-proof regulatory framework and support innovation and access to medicines in the EU. You can also find some examples of recent antitrust developments and investigations in the pharmaceutical sector under EU competition law from various articles^{3 4}. What kind of information are you looking for specifically? (The choices are: I want to know more about excessive pricing cases. I want to know more about merger review cases. I want to know more about clinical trial applications.) Learn more: 1. ema.europa.eu 2. health.ec.europa.eu 3. lexology.com 4. findcourses.co.uk 5. gov.uk 6.europeanpharmaceuticalreview.com

Updates:

Date	Update
11 May 2023	Updated first paragraph of the post with the information that Microsoft is opening/has opened New Bing to all users without a waitlist as long as they’re signed into the search engine via Microsoft’s Edge browser.