The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
FDA Issues New Guidance on cGMP for Combination Products
The guidance provides an overview of FDA’s 2013 final rule and the role of the different agency components with respect to cGMP for combination products. The guidance also offers specific advice on applying certain cGMP requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to combination products. Perhaps most noteworthy in the guidance is FDA’s advice on cGMP compliance for specific types of combination products—namely, prefilled syringes, drug-coated mesh, and drug-eluting stents. This specific guidance includes hypothetical scenarios for the various product types, primarily focusing on how to streamline cGMP for those products.
Although FDA regulations permit comments to a draft guidance to be submitted at any time, the agency is requesting that interested parties submit comments on the draft guidance within 60 days of publication in the Federal Register, meaning comments will likely need to be submitted by late March 2015. We will continue to monitor future developments in this area, as FDA is likely to rely on this guidance as a tool for inspections and enforcement moving forward. The draft guidance can be found at the following link.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017