Last updated: 20 March 2023
See updates at the end of this post.
Since the end of November 2022, the internet has been abuzz with news about a chatbot called ChatGPT (which is a Generative AI). Many of you will no doubt have used chatbots in your day to day lives and experienced the frustration of receiving poor responses or the same response over and over again. The chatbots that I have used thus far e.g. on those bank or shopping have not been particularly useful or illuminating. It always seems as though banks and/or retailers generally make a half-hearted stab at creating these chatbots with the sole intent of frustrating the living daylights out of the user! The number of really useful chatbots are few and far between.
Enter ChatGPT, a chatbot on steroids! Having read several articles about ChatGPT piqued my curiosity so I decided to give it a try. I asked it a number of regulatory affairs related questions. I thought it would be an idea to share my experience in order to alert you to the potential of this chatbot in case you haven’t already had a go at asking it questions of your own.
Who invented ChatGPT?
It was invented by OpenAI an artificial intelligence (AI) research laboratory which was founded in San Francisco in late 2015 by Sam Altman, Elon Musk and others. Musk resigned from the board in February 2018 but remained a donor. The company conducts research in the field of AI with the stated goal of promoting and developing friendly AI in a way that benefits humanity as a whole.
What is ChatGPT?
OpenAI describes ChatGPT as follows:
“We’ve trained a model called ChatGPT which interacts in a conversational way. The dialogue format makes it possible for ChatGPT to answer follow-up questions, admit its mistakes, challenge incorrect premises, and reject inappropriate requests.”
When was ChatGPT released and where can you access it?
On 30 November 2022, OpenAI released ChatGPT to get user feedback and learn about its strengths and weaknesses. During the research preview, usage of ChatGPT is free. You can try it now at chat.openai.com.
Other ways to access ChatGPT technology
OpenAI has launched a pilot subscription plan for ChatGPT Plus (currently or US users only) and you can join the waiting list here.
Microsoft has announced that Teams Premium is now generally available, with AI features drawing on Large Language Models powered by OpenAI’s GPT-3.5.
Microsoft has brought ChatGPT-powered New Bing to Windows 11 in latest update. Available from 28 Feb 2023 as part of Microsoft’s latest Windows 11 update, the Bing app sits in your PC’s taskbar where it will be accessible via a search box, so you can ask the bot questions at any time without having to open the Edge web browser.
Microsoft has released an update to Edge that brings a new sidebar that allows quick access to the Bing chatbot. Initially, the feature was available only in test versions, but now it has been rolled out to regular Windows and MacOS users.
Technology based on the same language-learning model as ChatGPT, is being added by Microsoft to its most ubiquitous work software, Microsoft 365. Microsoft is calling the system Copilot and says it will be embedded into Word, Excel, PowerPoint, and Outlook. The functions of Copilot include e.g. drafting emails, Creating PowerPoint presentations, including images, from prompts etc. Roll-out details have yet to be revealed.
Is there a guide on how to use ChatGPT effectively?
Of the many articles on ChatGPT that are available on the world wide web, I came across this one which provides quite comprehensive information on how to use ChatGPT effectively.
Some questions that I asked, the responses received and some thoughts on ChatGPT
I asked a number of questions to ChatGPT. At the end of this post are some of the questions that I asked and the responses received. It goes without saying that you should not use the responses to any of the questions, in the preparation of your registration applications, without doing your own due diligence.
Leaving aside the correctness of the responses, I was surprised and amazed at the level of detail provided in some of the responses as well as the professional manner in which the responses are presented in well written sentences. It is of course difficult to establish whether the responses have just been picked up from some website(s) on the internet. It seems as though the responses are at least as good as if not better than the responses that one might receive from a human being.
It is important to remember that this is only the first iteration of ChatGPT. If this is what it can do on its first outing, one can only imagine what it will be able to achieve over the next iterations. If ChatGPT is a glimmer of the added value that AI might bring to regulatory affairs, it looks very promising and I look forward to trying out future iterations of ChatGPT if OpenAI is benevolent enough to share them widely as it has done on this occasion. Even more interesting to follow will be its transition into the commercial environment once all the testing is as complete as it can be for the first release.
As regards the current capabilities of ChatGPT, Sam Altman the CEO of OpenAI, the company that invented ChatGPT, sums it up nicely:
Is there a way to check whether a piece has been written by a human or an AI?
A student who is in his senior year at Princeton university has developed an app, GPTZero, as a first step to address a host of concerns that could arise as artificial intelligence becomes smarter and more easily accessible. He is still working on improving GPTZero, but he has released a beta version for public use.
He has also tested the app by feeding it BBC articles written by journalists, versus articles written by ChatGPT using the same headline as a prompt. (He formerly worked with the BBC’s investigations unit). He said the app successfully guessed the difference between the texts with a less than 2% false positive rate.
Source: BBC
How do responses from ChatGPT compare with those from New Bing (Microsoft)?
See post dedicated this question.
How do responses from ChatGPT compare with those from New Bing (Microsoft) and Google’s Bard?
See post dedicated to this question.
Which version of the GPT architecture is ChatGPT based upon?
On 14 March 2023 OpenAI released GPT-4, the latest version of its hugely popular artificial intelligence chatbot ChatGPT. According to OpenAI, ‘GPT-4 is available on ChatGPT Plus and as an API for developers to build applications and services’. ChatGPT Plus is a subscription based service. You can read more about the capabilities of GPT-4 on the OpenAI website.
According to Open AI, GPT-4 :
- is more creative and collaborative than ever before. It can generate, edit, and iterate with users on creative and technical writing tasks, such as composing songs, writing screenplays, or learning a user’s writing style.
- can accept images as inputs and generate captions, classifications, and analyses.
- is capable of handling over 25,000 words of text, allowing for use cases like long form content creation, extended conversations, and document search and analysis.
Currently, it would appear that the free version of ChatGPT continues to be based on GPT-3 -architecture as per its response on 15 March 2023 (see below) to the question Which version of GPT are you using currently?
Microsoft confirmed on the same day that New Bing is is running on GPT-4, which has been customized for search.
Below are the questions that I asked ChatGPT and the responses received:
Question 1
How is CAR-T Cell therapy regulated in the European Union?
Answer
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.
Question 2
How long does it take to licence a biological product in the US?
Answer
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.
Question 3
I wish to market a medical device in the European Union. What route of authorisation must I follow?
Answer
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.
Question 4
What licensing routes are available in the European Union to licence medicines?
Answer
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.
Comment: The chatbot missed out the decentralised procedure.
Question 5
I wish to licence a cancer medicine in the USA. Which licensing route is most appropriate?
Answer
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.
Question 6
What are the different stages of drug product registration in Mexico?
Answer
The stages of drug product registration in Mexico typically include the following:
- 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.
- 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.
- 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.
- 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.
- 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.
Question 7
I wish to licence a generic medicine in the UK. What data must I submit to the MHRA?
Answer
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:
- A comprehensive description of the generic medicinal product, including its composition, formulation, and manufacturing process.
- Clinical data, including data on the bioequivalence of the generic medicinal product to the reference medicinal product.
- A summary of the product’s benefits and risks.
- A risk management plan outlining the measures that will be taken to ensure the safe and effective use of the product.
- Quality data, including data on the quality, safety, and efficacy of the generic medicinal product.
- A statement of the product’s therapeutic equivalence to the reference medicinal product.
- 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.
- A declaration of the product’s compliance with good manufacturing practices (GMP).
- A declaration of the product’s compliance with good clinical practices (GCP).
- A declaration of the product’s compliance with good laboratory practices (GLP).
- A declaration of the product’s compliance with good distribution practices (GDP).
It is advisable to consult the MHRA’s guidelines on the licensing of generic medicinal products and seek guidance from a qualified regulatory affairs professional to ensure that all necessary documentation is properly prepared and submitted.
Question 8
Under the Clinical Trials Regulation (EU) No 536/2014, what documentation is required for the authorisation of a clinical trial?
Answer
Under the Clinical Trials Regulation (EU) No 536/2014, the following documents are required for the authorization of a clinical trial:
- 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).
- An investigator’s brochure: This is a document that provides detailed information on the IMP, including its composition, pharmacology, and toxicology.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Comment: The above response has correct elements to it but it does not include a list of documents as laid out in the regulation.
Question 9
What registration samples are required to register a pharmaceutical product in India?
Answer
To register a pharmaceutical product in India, the following samples are generally required:
- 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.
- 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.
- Raw material samples: These are samples of all the raw materials that will be used in the manufacture of the finished product.
- Packaging material samples: These are samples of all the packaging materials that will be used to package the finished product.
- In-process material samples: These are samples of materials that are intermediate products produced during the manufacturing process.
- Laboratory control samples: These are samples of the finished product that are used to verify the accuracy of the laboratory control tests.
- 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.
Question 10
Is there a way to easily find information on ongoing or recently completed pharmaceutical cases in the EU?
Answer
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:
- 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.
- 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.
- 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.
- 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.
Updates
| Date | Update(s)Updated section entitled |
|---|---|
| 9 Apr 2023 | New section added entitled How do responses from ChatGPT compare with those from New Bing (Microsoft) and Google’s Bard? |
| 20 Mar 2023 | Section entitled Other ways to access ChatGPT technology updated to add information about: 1) Microsoft updating Edge bringing a new sidebar that allows quick access to the Bing chatbot. 2) Technology based on the same language-learning model as ChatGPT being added by Microsoft to its most ubiquitous work software, Microsoft 365. |
| 16 Mar 2023 | 1) Section entitled Which version of the GPT architecture is ChatGPT based upon? updated to reflect Microsoft confirmation that New Bing is running GPT-4. 2) Section entitled Other ways to access ChatGPT technology updated to reflect current information on chatGPT powered New Bing. |
| 15 Mar 2023 | New section entitled Which version of the GPT architecture is chatGPT based upon? added. |
| 28 Feb 2023 | 1) Updated section entitled Other ways to access ChatGPT technology to add information on availability of ChatGPT-powered Bing to Windows 11 in latest update. 2) Added nee section entitled How do responses from ChatGPT compare with those from New Bing (Microsoft)? |
| 10 Feb 2023 | Added information on chatGPT Plus to the section entitled Other ways to access ChatGPT technology. Added the section entitled Is there a guide on how to use ChatGPT effectively? plus relevant content. |
| 9 Feb 2023 | Added the section entitled Other ways to access ChatGPT technology plus links to relevant content. |
| 3 Feb 2023 | Added the section entitled Is there a way to check whether a piece has been written by a human or an AI? plus relevant content. |