Pharmaceutical Guidelines — regulatory updateshttps://www.pharmaguideline.net/updates/Pharma regulatory updates explaineden-inICH Q2(R2) and Q14: new analytical validation and development guidelineshttps://www.pharmaguideline.net/updates/2023-11-01-ich-q2r2-q14-step4/https://www.pharmaguideline.net/updates/2023-11-01-ich-q2r2-q14-step4/Fri, 16 Oct 2026 00:00:00 GMTICHICH 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.Revised Schedule M (G.S.R. 922(E)): what changed in India's GMP rules and the deadlineshttps://www.pharmaguideline.net/updates/2023-12-28-revised-schedule-m-gsr-922e/https://www.pharmaguideline.net/updates/2023-12-28-revised-schedule-m-gsr-922e/Fri, 16 Oct 2026 00:00:00 GMTOtherG.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 13485https://www.pharmaguideline.net/updates/2024-02-02-fda-qmsr-final-rule/https://www.pharmaguideline.net/updates/2024-02-02-fda-qmsr-final-rule/Fri, 16 Oct 2026 00:00:00 GMTFDAFDA'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)https://www.pharmaguideline.net/updates/2026-04-11-ich-q1-stability-draft/https://www.pharmaguideline.net/updates/2026-04-11-ich-q1-stability-draft/Fri, 16 Oct 2026 00:00:00 GMTICHDraft 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)https://www.pharmaguideline.net/updates/2026-07-30-pics-pi-006-4-qualification-validation/https://www.pharmaguideline.net/updates/2026-07-30-pics-pi-006-4-qualification-validation/Fri, 16 Oct 2026 00:00:00 GMTPIC/SPIC/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 sampleshttps://www.pharmaguideline.net/updates/2026-09-23-pics-gmp-guide-pe-009-18/https://www.pharmaguideline.net/updates/2026-09-23-pics-gmp-guide-pe-009-18/Fri, 16 Oct 2026 00:00:00 GMTPIC/SPIC/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.