medicines-medical devices-regulatory affairs
This post is an attempt to provide basic information on the Swissmedic Marketing Authorisation for Global Health Products (MAGHP) and the MAGHP Light procedures. The MAGHP and MAGHP Light Procedures are part of Swissmedic’s engagement in development cooperation, in accordance…
Title of guidance Type and level of guidance About the guidance Source Providing Over-the-Counter Monograph Submissions in Electronic Format Draft This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act) (21 U.S.C. 355h)…
Last updated: 21 September 2022 See list of updates at the end of the post. Report and minutes from the CMDh meeting held on 19-20 July 2022 The CMDh minutes are a full record of the CMDh meetings (minus redaction…
Guidance No About the guidance MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6)…
Last updated: 20 February 2026 This post is an attempt to provide an information resource for Advance Therapy Medicinal Product (ATMPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each…
Updates to the EU Compilation of Union Procedures on Inspections and Exchange of Information, were adopted in September 2021 with a period of 9 months (following publication) before coming into force i.e. June 2022. The changes are relevant for holders of GMP…
The Rules Governing Medicinal Products in the European Union : Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Revision to Annex 1: Manufacture of Sterile Medicinal Product Volume 4 of “The rules…
Health Canada has updated guidances concerning pre and post-licensing submissions and performance standards for PDCs for prescription pharmaceutical drugs and those administered or obtained through a health professional. Notice: Revision to the Guidance Document Management of Drug Submissions and Applications…
The UK MHRA has launched an Innovation Accelerator service. The service will help provide innovators access to MHRA scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more…
On mobile, the table below is best viewed by scrolling sideways. Title of guidance Type and level of guidance About the guidance Source Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Draft guidance This guidance (Guidance 3)…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timelycompliance with MDR requirements From 27 May 2024, the MDR will be fully applicable…
On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs. Accordingly, affected stakeholders (e.g. manufacturers, EU importers and distributors, authorised representatives) are required to act in accordance…