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 The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain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 FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?
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.
ANVISA´s Q&A on Medical Cannabis for Clinical Investigations
The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?
CTIS & EudraVigilance - Update for Sponsors of Clinical Trials
The EMA provides guidance for sponsors who have to report SUSARs via EudraVigilance originated in the context of clinical trials. In addition the updated document "Key Information for Sponsors on CTIS" has been published.
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?
Swissmedic´s New Website for Herbal Medicinal Products
The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".