GMP News Drug Safety/Pharmacovigilance

To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.

The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to the agency. Read more about FDA´s regional ICH E2B (R3) Implementation Guideline.

The FDA issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.  

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

Due to a change in REACH, the Ph. Eur. is considering to replace the plasticiser DEHP and is therefore seeking information from manufacturers. The deadline for replies is 30 September 2022.

The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?