medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
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…
On 25th October 2021, the Indian Department of Pharmaceuticals (DoP) issued a draft policy document to catalyse R&D and innovation in the Pharma and Med-Tech sector in India. There is the scope to provide feedback on the draft by 6…
Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products to version 1.1. This position paper could be of interest amongst others, to anyone who has an interest in the increasing digitisation and/or digitalisation of clinical…
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 European Medicines Agency (EMA) has provided guidance to MAHs on last submission dates for Type I and II variations for human medicines, in 2021. (MAHs) are advised to submit variations as follows: Variation type To be submitted no later than…
The UK, US and Canadian regulators have identified ten guiding principles to be addressed when medical devices use Artificial Intelligence (AI) or machine learning software. AI and machine learning technologies have the potential to transform health care by deriving new…
The European Commission (EC) has established a portfolio of the ten most promising treatments for COVID-19. A group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as the most promising for the…
Artificial (AI) is slowly but inexorably creeping into our lives in everything that we do. Not a day goes by without new stories in the press about some new use of AI e.g. bringing Roman emperors back to life or…
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…