EMA launch of International Sterile Medicines Inspection Pilot Program

European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.

Specifically, the program will allow information sharing from GMP inspections of manufacturers located in countries that are not participating in the pilot and to promote organize joint inspections.

Lasting a minimum of 2 years, this pilot will involve:

  • EMA
  • US FDA
  • UK’s MHRA
  • France’s ANSM
  • Australia’s TGA
  • Health Canada
  • Japan’s PMDA
  • World Health Organisation

Throughout the program, participants will coordinate and share their inspection plans alongside other participating authorities. This effort will see inspections being done according to predefined GMP requirements, encouraging the coordination of joint inspections rather than sole or concurrent inspections.

This pilot would be applicable to human drugs and certain therapeutic biologics, such as monoclonal antibodies and recombinant proteins, excluding vaccines, cell and gene therapies and plasma-derived products.

European Commission released 8 documents for unique device identifiers (UDIs) for medical devices

The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices.

4 of them are relating to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose.  These UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA respectively. The other 4 documents would deal with UDI human readable interpretation (HRI) formats, including HRI qualifiers for UDI-DI, lot number, expiration date, serial number and manufacturing dates.

More details can be found in the EC website:
https://ec.europa.eu/docsroom/documents/35241?locale=en
https://ec.europa.eu/docsroom/documents/35242?locale=en

European Commission released an aide memoire on practicing good distribution practice (GDP)

The European Commission released an aide memoire to assist pharmaceutical wholesalers in practicing good distribution practice (GDP).

The 6 page document ranges from a form of general questions to specific questions relating to quality systems, verification of a medicine’s safety features, suspected falsified medicinal products and decommissioning of unique identifiers (UIs).

The aide memoire can be download from the EC website:
https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/inspection_gdp_aidememoire_en.pdf

Eudamed upcoming plans

The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been done.

They have decided to launch the database simultaneously for both medical devices and in-vitro diagnostics come May 2022.

This means that device manufacturers can now postpone their entering of data into Eudamed.

As compared to the current database, the new Eudamed2 will contain different modules

  • Actors
  • Unique Device Identifiers
  • Notified bodies and certificates
  • Vigilance clinical investigation performance studies
  • Market surveillance