medicines-medical devices-regulatory affairs
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)…
The UK MHRA has updated its guidance on Orphan medicinal products. The original guidance was first published 1 September 2020, then republished on 31 December 2020. Information on the following has now been added: How a review of market exclusivity…
The MHRA has updated its guidance on applying for a variation to your marketing authorisation. The original guidance was published in December 2014. Following the end of the transition period on 31 December 2020, the guidance has been updated with…
The UK MHRA has updated is guidance on variations to Marketing Authorisations (MAs) from 1 January 2021. The original guidance was published on 27 October 2020. In the latest update, further information is provided on variations for products that were…