Developments in 2018

European Mutual Recognition Agreement

In 2017 FDA and the European Union entered into a Mutual Recognition Agreement to use one another’s GMP inspection results for pharmaceutical manufacturing facilities. The initiative became effective November 2, 2017. FDA is currently in the process of evaluating each of the 28 EU countries’ drug inspectorates to determine whether they are capable of meeting FDA’s requirements. As of the date of publication, the following 20 countries’ regulatory authorities have been deemed capable: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Spain, Sweden and the United Kingdom. The Mutual Reliance Initiative will enable FDA to avoid duplication, reduce costs and focus its resources in other parts of the world where there is greater public health and safety risk.

GMP for 503B Outsourcing Facilities

In December, FDA issued the Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act draft guidance, which describes the agency’s policies regarding cGMP for facilities that compound human drugs and register as outsourcing facilities under section 503B of the FDCA (503B facilities). FDA intends to promulgate specific cGMP regulations for 503B facilities. The draft guidance is intended to outline the conditions under which FDA does not intend to take enforcement action against 503B facilities until the agency issues the 503B-specific cGMP regulations. The draft guidance replaces the July 2014 Current Good Manufacturing Practice – Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act draft guidance. It includes considerations for non-sterile compounded drug products and differentiates between requirements applicable to sterile and non-sterile compounded drug products where appropriate. The draft guidance also includes changes relating to stability testing (adding a “beyond-use date” as an expiration date) and release testing requirements. Finally, the draft guidance addresses reserve samples and provides guidance on “in-use times.”     

Read more on FDA 2018 Year in Review.