European Union - January 17 2023
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good…
Giuseppe Aminzade, David Horowitz, Ted Lis, Mikael Salmela, Joerg Schickert, Jane Summerfield
European Union - January 12 2022
The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in…
Nikoleta Kyriazopoulou, Grégoire Paquet
European Union - January 6 2022
The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain…
Nikoleta Kyriazopoulou
European Union - September 28 2021
The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This…
Claudia Mendes Pinto
USA - September 22 2021
In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with…