Update log
What changed in CMCfy, and when.
We check every guideline CMCfy cites against the agencies’ own sites. When a new version comes into force, the tools, the review checklists and the training guides are updated within 30 days, and the change is listed on the update log. Citations last checked against the agencies’ sites on 30 October 2026.
Releases
Changes, newest first
| Date | Area | Change |
|---|---|---|
| 31 October 2026 | Validation and security | Trust Center and Validation & Security Pack One page and one PDF for your QA and IT reviewers: where data goes, the providers we use, how CMCfy maps to 21 CFR Part 11 and EU GMP Annex 11, and the validation documents. |
| 31 October 2026 | Modules | Lab Notebook Record experiments from templates, attach any file, sign and witness entries, and send signed results straight into the matching report tool. |
| 31 October 2026 | Modules | Write the report with CMCfy CMCfy Writer drafts the narrative from your data and protocol, lists the gaps for you to accept or ignore, and takes edits in plain words. Numbers still come from fixed rules. |
| 31 October 2026 | Modules | Stability Studio: several tests at once Assay, impurities, dissolution and other attributes evaluated together, each with its own ICH Q1E shelf life. |
| 31 October 2026 | Validation and security | Release protection Tool code is minified and fingerprinted per release; stricter security headers on every tool page. |
| 30 October 2026 | Guidance | All citations checked against the agencies’ sites Every guideline cited by the tools, the review and the training guides was checked. New in force: EU variations guidelines C/2025/5045 (from 15 January 2026, new Q-codes), FDA nitrosamine less-than-lifetime guidance (24 September 2026), ICH E6(R3) Annex 2 and the FDA QMSR (2 February 2026). |
| 30 October 2026 | Validation and security | “Guidances applied” in every tool and report Each tool page and every Word or PDF report lists the guidelines and versions the data was compared with. |
| 30 October 2026 | Modules | FDA inspections Mock inspection readiness, Form 483 and warning letter responses, a remediation tracker and FDA citation trends. |
| 30 October 2026 | Modules | FDA submissions, clinical, devices, EPA and USDA Full IND, NDA/BLA and eCTD planning; ICH M11 protocols and E3 study reports; 510(k), De Novo and PMA, design history file and ISO 14971; EPA pesticide registration; USDA veterinary biologics. |
| 30 October 2026 | Modules | Nitrosamines, Q3D, E&L, sterilisation, nonclinical and more Nitrosamine risk assessment, elemental impurities, extractables and leachables, sterilisation validation, CPV, CSV summary, complaints and recalls, self-inspection, peptides and oligonucleotides, vaccine lot release, Japan/Canada/WHO filings and nonclinical reports. |
| 29 October 2026 | Modules | Protocol Builder and full CMC coverage Protocols for each study type, and modules for PPQ, cleaning validation, change control, APR/PQR, Module 1 CMC items, post-approval filings, DMF/ASMF, method transfer, comparability and cell and gene therapy. |
| 28 October 2026 | Validation and security | Projects, versions, audit trail and IQ/OQ pack Projects in your own folder, numbered versions, a chained audit trail, your logo on reports, and the automated IQ/OQ with supplier validation documents. |
| 28 October 2026 | Modules | Report preview and review before download Every export opens a preview listing gaps in the data, the report and against your protocol, then downloads as Word or PDF. |
Coming next
Guideline revisions we are watching
| Expected by | Guideline | What is changing |
|---|---|---|
| 30 November 2026 | Stability testing (Q1A(R2), Q1B, Q1D, Q1E; Q5C for biologics) | ICH Q1 consolidated revision (merges Q1A–Q1F and Q5C): Step 2 draft April 2025; Step 4 planned at the ICH Assembly, Prague, 17–18 November 2026 |
| 31 December 2026 | Residual solvents Q3C(R9) | Q3C(R10): revised PDEs for DMF, dichloromethane and ethylene glycol; Step 4 planned December 2026 |
| 31 January 2027 | Directive 2001/83/EC and Regulation (EC) No 726/2004 | EU pharma package (new Directive and Regulation repealing 2001/83/EC and 726/2004): adoption and Official Journal publication expected late 2026; most provisions apply 24 months after entry into force |
| 31 March 2027 | EU GMP Part I, Annex 1 (2022), Annex 11 (2011), Annex 15 (2015), Annex 16 (2016) | Revised Annex 11, Chapter 4 and new Annex 22 (artificial intelligence): drafts July 2025, consultation closed October 2025; final texts awaited |
| 30 June 2027 | Validation of analytical procedures Q2(R2) and analytical procedure development Q14 | USP <1225> revision aligned with Q2(R2)/Q14 proposed in Pharmacopeial Forum 51(6); USP <1225> as published stays official until then |
| 30 June 2027 | CTD quality M4Q(R1) | M4Q(R2) restructures Module 2.3 and 3: Step 2 draft May 2025; consultation closed March 2026; Step 4 planned June 2027 |
| 31 August 2027 | Container Closure Systems for Packaging Human Drugs and Biologics | Draft Container Closure Systems for Human Drugs and Biological Products (FDA-2026-D-7957, 14 August 2026) will replace the 1999 guidance and the 2002 Q&A when final |
| 30 September 2027 | Pesticide registration: FIFRA section 3, 40 CFR 152 (procedures, data citation), 40 CFR 158 (data requirements), 40 CFR 160 (GLP), 40 CFR 156 (labeling), 40 CFR 180 (tolerances); PR Notices 86-5 and 98-5; PRIA 5 | PRIA 5 fee and decision-time tables run to 30 September 2027; reauthorisation (PRIA 6) expected before then |
When one of these comes into force, the affected tools are updated and the change is added above.
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Write to us and we will send release notes to your QA contact with each release.