medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…
The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears…
The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional experience to be gained. About the SNSA pilot The EU Innovation Network started a…
The European Medicines Agency has recently published a 29 page Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation holders (MAHs). Whilst it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products…
The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…
There are currently a couple of EU clinical trials related guidelines under consultation. Both guidelines must be considered in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came…
The Medical Devices Regulation (EU) 2017/745 (MDR) becomes applicable in the European Union today, 26 May 2021. The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC). It entered into force in May 2017 and had a staggered transitional period. It…
On 26 March 2021, the European Medicines Agency (EMA) has signed a confidentiality agreement with ANVISA, the Brazilian regulatory authority. The agreement is valid for an indefinite period of time and does not require a renewal. It provides the framework under…
The EMA has published a Q&A on the principles of GMP for the manufacturing of startingmaterials of biological origin used to transfer genetic material for the manufacturing ofAdvance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for manufacturing and…
The EMA has updated its post-authorisation procedural advice for users of the centralised procedure. The Q & A advice document has been updated from the version of 11 January 2021 EMEA-H-19984/03 Rev. 88 to the version of 8 February 2021…