medicines-medical devices-regulatory affairs
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: 28 June 2025 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…
The EMA has updated its post-authorisation procedural advice for users of the centralised procedure. The latest version of the Q & A advice document, Rev. 99 is dated 20 June 2022. Here, you can view the track changed and clean…
The TGA has responded to the issues raised in the 2021 Report on Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives Background First introduced in May 2011, the regulatory framework for biologicals provides the legislative basis for the…
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 FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0862 on Regulations.gov. …