The PSUR bulletin for the week commencing 29 June 2015 is now available.

The ICH E6(R3) draft Guideline on “Good Clinical Practice (GCP)” has reached Step 2 of the ICH process on 19 May 2023.

Added in May 2023 22 May NEW - 23-25 May agenda 3 May UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”  UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines UPDATE [...]

The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process on 3 April 2023.

The ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process in January 2023.

The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023.

CMDh letter to MAHs of tenofovir disoproxil-containing medicinal products (February 2023)

Report from the meeting held on 23-25 May 2023 Report from the meeting held on 24-25 April 2023 Report from the meeting held on 28-30 March 2023 Report from the meeting held on 21-22 February 2023 Report from the meeting held on 24-26 January 2023

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022.

A Step 2 Informational Presentation has been developed by the M13 Expert Working Group, in follow up to the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of the ICH Process in December 2022.