Guidelines tracker: ICH, FDA, EMA, MHRA
14 November 2026
New, draft and final guidance as it is published: FDA notices of availability (including the ICH guidelines FDA adopts) from the Federal Register, EMA scientific and procedural guidelines and public consultations (including ICH texts adopted in the EU), and MHRA guidance. Each entry links to the official document.
PharmacovigilanceGuideline · draft
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - List of medically important (MI) VeDDRA terms
🇪🇺 EMA · Fri 13 Nov 2026
RegulatoryGuideline · revised
Reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products - Revision 1
🇪🇺 EMA · Fri 13 Nov 2026
PharmacovigilanceGuideline · final
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
🇪🇺 EMA · Mon 09 Nov 2026
RegulatoryGuideline · draft
Draft guideline on predictive biomarker assays in the context of medicinal product lifecycle
🇪🇺 EMA · Mon 09 Nov 2026
RegulatoryGuideline · draft
Draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information - Revision 1
🇪🇺 EMA · Mon 09 Nov 2026
Clinical trialsGuideline · final
Notice to sponsors on validation and qualification of computerised systems used in clinical trials
🇪🇺 EMA · Wed 28 Oct 2026
RegulatoryGuideline · final
Recommended submission dates for veterinary medicinal products
🇪🇺 EMA · Tue 20 Oct 2026
RegulatoryGuideline · final
Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
🇪🇺 EMA · Mon 19 Oct 2026
RegulatoryGuideline · draft
Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports
🇪🇺 EMA · Mon 19 Oct 2026
RegulatoryGuideline · concept paper
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)
🇪🇺 EMA · Mon 19 Oct 2026
RegulatoryGuideline · final
Reflection paper on methodological aspects in confirmatory platform trials
🇪🇺 EMA · Mon 19 Oct 2026
Clinical trialsGuideline · concept paper
Concept paper on clinical trials in recipients of kidney transplantation
🇪🇺 EMA · Fri 16 Oct 2026
RegulatoryGuideline · draft
Draft reflection paper on the investigation of drug interactions of herbal medicinal products
🇪🇺 EMA · Thu 15 Oct 2026
Quality & complianceGuideline · final
Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards
🇪🇺 EMA · Fri 09 Oct 2026
RegulatoryGuideline · draft
Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products
🇪🇺 EMA · Thu 08 Oct 2026
RegulatoryGuideline · final
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
🇪🇺 EMA · Tue 06 Oct 2026
RegulatoryGuideline · final
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
🇪🇺 EMA · Tue 06 Oct 2026
RegulatoryGuideline · final
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
🇪🇺 EMA · Tue 06 Oct 2026
RegulatoryGuideline · final
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
🇪🇺 EMA · Tue 06 Oct 2026
PharmacovigilanceGuideline · concept paper
Concept paper on the guideline revision on good pharmacogenomic practice
🇪🇺 EMA · Tue 06 Oct 2026
RegulatoryGuideline · final
List of centrally authorised products with safety-related changes to the product information
🇪🇺 EMA · Fri 02 Oct 2026
ICH's own website can't be monitored automatically, so ICH guidelines are tracked through FDA's Federal Register notices and EMA's guideline feeds, the two routes by which ICH texts take effect in the US and EU.