medicines-medical devices-regulatory affairs
The European Commission has published a comprehensive study report on medicines shortages in the EU. A very brief overview of the study is available here. About medicines shortages in the EU Medicine shortages present a growing problem for many EU/EEA…
The European Parliament has adopted a report calling for increased use of off-patent medicines in Europe to improve patient access, highlighting lessons learned during the Covid-19 pandemic and urging the European institutions to address them directly in future healthcare policy…
The TGA, Australia has updated several updated guidance documents on aspects of Australian manufacturing licences and overseas GMP certification. 1) Applying for a manufacturing licence for an Australian manufacturing site This updated step-by-step, 47 page guide (version 2.2, Dec 2021) with…
Last updated on: 24 November 2021. See update at the end of the post. TGA, Australia is consulting on the remaking of some TGOs and other legislative instruments for human cell and tissue (HCT) products. What are Therapeutic Good Orders…
The FDA has recently updated its information on possible mitigation strategies to reduce the risk of nitrosamine drug-substance related impurities in drug products (NDSRIs). Guidance for industry on nitrosamine was published in September 2020 and updated in February 2021. A…
Hologic has launched its Artificial Intelligence (AI) based Genius Digital Diagnostics system in Europe, for cervical cancer screening. The burden of cervical cancer in Europe According to a study by the EPF in 2020: Current estimates indicate that every year, 61,072…
Health Canada has published an update on Update on the Implementation of ICH’s Q12 Guideline and Pilot Programs. What is the ICH 12 guideline about? The ICH guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12)…
The FDA CDER Export Certificate Program is being modernised, with a move soon to electronic Certificate of a Pharmaceutical Product (eCPPs). Who are the end users of CPPs? Manufacturers exporting products from the U.S. are often asked by foreign customers…
The TGA, Australia has provided an update on its GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. The update concerns certain temporary measures introduced in 2020 for overseas manufacturers. The following items are addressed: On-going…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746This document presents questions and answers…
The EU Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation. This is part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector and the latest step towards an…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 8 May 2020 – 23 September 2021 is covered. On mobile, the table is best…