Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR

Radiopharmaceuticals - Scientific guideline

Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products

Update: Guidance document: preparation of regulatory activities in non-eCTD format

ICH E6 (R2) Good clinical practice - Scientific guideline

Testing of Glycerin for Diethylene Glycol

Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurised metered dose inhalers

Annex to the evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist

European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle

Concept paper on the development of a guideline on the quality aspects of mRNA vaccines

Decision on rules concerning the handling of declared interests of national experts on secondment, trainees, interims and visiting experts of the European Medicines Agency

Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b

Q9(R1) Quality Risk Management

Regulatory science strategy

Guideline on computerised systems and electronic data in clinical trials

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality

PRIME eligibility requests: 2024 deadlines for submission and timetable for assessment

Scientific advice under Art.107(6) of Reg.(EU)2019/6 for establishment of a list of antimicrobials which shall not be used in accordance with Art. 112, 113 and 114 or which shall only be used in accordance with these articles subject to certain conditions.

European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - step 5 - Revision 4

Q&A on the Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU

Evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist

Questions and Answers about the raw data proof-of-concept pilot for industry