medicines-medical devices-regulatory affairs
Last updated: 27 February 2023 See updates at the end of the post. EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 Revision 1 of the above document dated 15 Feb…
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…
The EMA has published a Q&A on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of Advance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for…