In the USA, combination products are regulated independantly. A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.
With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.
FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.
With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.
After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.
The French National Agency for Medicines and Health Products Safety carries on the work on medical cannabis started in 2018 and has now published a dossier on cannabis for medical use.
A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.
A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.
The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.
The European Commission (EC) published an updated Version 2.2 of the Questions & Answers relating to the Clinical Trials Regulation.