ICH Q2(R2) and Q14: new analytical validation and development guidelines
ICH Q2(R2) and Q14 were adopted at Step 4 on 1 November 2023. What changed from Q2(R1) and what QC labs should review in their method lifecycle.
Regulatory updates
New guidance from CDSCO, FDA, EMA, ICH, PIC/S, WHO and the pharmacopoeias, explained in plain English: what changed, who it affects, the key dates and what to do now. Every update links to the official document.
Revised Schedule M (G.S.R. 922(E)): what changed in India's GMP rules and the deadlines
G.S.R. 922(E) of 28 December 2023 replaced Schedule M of the Drugs Rules, 1945. What it adds, who must comply, and the timelines including the 2025 extension.
FDA QMSR now in effect: 21 CFR Part 820 aligned with ISO 13485
FDA's Quality Management System Regulation took effect on 2 February 2026, incorporating ISO 13485:2016 into 21 CFR Part 820. What it means for device exporters from India.
Draft: ICH Q1 consolidated stability guideline (replaces Q1A–F and Q5C once final)
Draft ICH Q1 (Step 2, April 2025) merges Q1A–F and Q5C into one stability guideline. Draft only: not yet a final guideline.
PIC/S PI 006-4: revised Recommendations on Qualification and Validation (in force 1 Oct 2026)
PIC/S PI 006-4 replaces PI 006-3 and applies from 1 October 2026. What the document supersedes and the lifecycle approach it states.
PIC/S GMP Guide PE 009-18 in force: revised Annex 19 on reference and retention samples
PIC/S GMP Guide PE 009-18 took effect on 24 September 2026, adding the revised Annex 19 on reference and retention samples. What changed and what to check.