medicines-medical devices-regulatory affairs
The TGA, Australia has updated its guidance on the Declaration of Conformity (DoC) procedures for certain Class I medical devices. The guidance was originally published in December 2020. It has now been updated to Version 1.1 to include Class I…
The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals. The 17 page guidance document outlines: the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines…
Health Canada is consulting on its current policy on the regulation and classification of Drug-device combination products (DDCPs). Why is Health Canada consulting on this policy? Health Canada is updating its policy on DDCPs to provide more detail and clarity…
The TGA, Australia has published an update on the registration or variation of Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines. Module 1.2.1: Application form This application form must be used for the following Category 1 and COR…
Following a consultation in 2020, the UK MHRA has published detailed guidance on the licensing of biosimilar products. Who is the guidance for? The purpose of the guidance is to provide developers of similar biological medicinal products (aka biosimilars) with…
About PIC/S The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having…
The EMA has published a Q&A on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of Advance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for…
Last updated: 4 February 2022 See updates at the bottom of the page. The UK MHRA has provided guidance on how to complete your Electronic Application Form (eAF) and Cover Letter. The guidance has been provided as an electronic tool.…
The TGA, Australia has published a checklist for manufactures of medical devices to demonstrate compliance with the essential principles for their medical devices. TGA states that it is the manufacturer’s responsibility to demonstrate compliance with the essential principles for their…
Last updated: 23 August 2022 This post is an attempt to facilitate understanding of the basics of the UDI system, an EU identification system for medical devices introduced in the Medical Devices (EU) Regulation (EU) 2017/745 (MDR) and the In…
The European Commission (EC) has issued a notice on the handling of duplicate marketing authorisation applications (MAAs) of pharmaceutical products under Article 82(1) of Regulation (EC) No 726 Basically, this means duplicate MAAs for products authorised via the centralised procedure.…
The UK MHRA has updated its guidance on medical devices: EU regulations for MDR and IVDR (Northern Ireland). About the EU Medical Device Regulations The Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR)…