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

 

Last weeks round-up; 2 – 6 December 2019

EMA GUIDANCE ON NITROSAMINE ASSESSMENTS

CMDh has issued an update to the practical guidance on Nitrosamine assessments. It is confirmed that MAHs can combine several MAs in one template of the risk assessment step 1 outcome, where the outcome is the same. However, national requirements too as mentioned later in the guidance needs to be considered. The national requirements may not necessarily be overruled by the general possibility given by CMDh. The full guidance document can be found under this link https://lnkd.in/dBHf63p EMA

HMA/EMA BIG DATA TASK FORCE REPORTS

Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The EMA and HMA have established a joint task force to investigate the potential role of ‘big data’ in the context of medicines development and regulation in the EU. A series of Subgroup reports were issued on 27th Nov 2019, links to the different subgroup reports can be found here https://lnkd.in/dU6Kwu2. Topics include, Clinical Trial and Imaging, Genomics, Genetics Transcriptomics and Epigenetics, Observational Data and Bioanalytical Omics.

NEW CMDH BEST PRACTICE GUIDE ON MULTILINGUAL PACKAGING

A new CMDh Best Practice Guide on Multilingual Packaging was published this month, November 2019.  Multilingual packaging relates to the use of two or more languages on the immediate and /or outer packaging and/or package leaflet of a medicinal product. The published guidance is aimed to assist applicants in creating multilingual packages which are recognised for their importance in maintaining products in EU markets. To view the guidance in full, please see: http://bit.ly/37QiHOI

SECOND CORRIGENDUM OF MDR (EU) 2017/745 CONCERNING CLASS I MEDICAL DEVICES

The council of the European Union published the second corrigendum to the EU Medical Devices Regulation (MDR) on the 25th November. The most significant changes relate to Class I medical devices which are sterile, include a measuring function, or are reusable surgical instruments. The corrigendum will mean that manufacturers would have an additional 4 years up to 26th May 2024 to comply with the new regulations in full. The changes proposed in the second corrigendum must be formally adopted by the European Parliament to take effect. MDR Corrigendum 13081/19 is linked here https://bit.ly/381YEgB with the English version starting on page 43 of the document.

BREXIT MEDICINES SHORTAGES

EMA has just updated its Q&A document (Link – https://lnkd.in/dg7PUay ) on the work being done to avoid medicines shortages following the UKs exit from EU. Medicines agencies will make information on Medicines procedures available via usual means, therefore, there is also a link therein to where details of medicines subject to ongoing shortages in EU countries can be found.