Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements.
The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs).
LISBON – Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the RAPS Euro Convergence 2026 conference closing plenary; however, they cautioned that oversimplification could backfire and lead to more regulation down the road.
LISBON – Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical follow-up (PMCF) plan is realistic, according to experts who spoke at RAPS Euro Convergence 2026 on Thursday.
MedTech Europe has shared feedback on planned changes to the European Union’s medical device and diagnostic regulations, offering high-level support for the revisions while calling for tweaks to aspects of the proposals.
Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), announced a new pilot program promising one-day inspections for low-risk facilities on Wednesday.
LISBON – A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the EU Medical Device Regulation (MDR) at the RAPS Euro Convergence 2026 conference on Wednesday.
The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
