Last weeks round-up; 6 – 10 January 2020

EMA CMDH CLARIFIES THE PROOF OF GMP COMPLIANCE REQUIRED FOR US MANUFACTURING SITES

CMDh has amended the Q&A on the impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations. In particular, Q1 has been changed in relation to the documentation to be submitted in EU as proof of GMP compliance for US manufacturing sites that have been previously inspected by US FDA. Further information can be found under this link https://lnkd.in/dyj7ZJu

LAUNCH OF INTERNATIONAL PILOT PROGRAMME ON INSPECTION OF MANUFACTURERS OF STERILE MEDICINES

On the 17th of December, the EMA announced the launch of a pilot programme which would see cooperation between European and International partners of the EMA in the inspection of sterile medical device manufacturers. This programme would improve oversight of manufacturers as well as reduce the likelihood of duplicate of inspections. For further information, please see the following link: http://bit.ly/2FojYzB