News about GMP/cGMP

The proceedings have again picked up speed. The US FDA has now published the names of the first eight European Member States, that – according to the FDA – got the confirmed capability, capacity and procedures in place to carry out GMP-inspections at a level equivalent to the EU. To anticipate it: Germany is not included! The countries listed are:

• Austria
• Croatia
• France
• Italy
• Malta
• Spain
• Sweden, and
• the United Kingdom.

The remaining inspectorates will continue to be assessed until 15 July 2019.

The start of the operational phase is considered to be a major milestone and a testimony to mutual trust. It is unprecedented as the FDA has never before recognised another country’s inspectorate.  It is also a major milestone towards closer cooperation to improve the use of available resources to safeguard quality and safety of medicines. This addresses the fact that around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the Union.

To answer frequently asked questions on the subject, the EMA has also released a Q&A paper on the impact of the MRA. The document including 10 O&As can be found here. To read the EMA's press release, please click here.

Source:

EMA: Q&A Paper

EMA: News & Events