2026-09-04
Source coverage
Defined official-source coverage
This page exposes which manifest sources have explicit reviewer approval and which remain pending. A separate ingestion registry tracks whether approved material is live in the index.
EU/EEA documents52
ICH guidelines76
Authorities8
Source freshness and version policy
Operator-reviewed source updates before production releases and when high-change regulatory frameworks are updated.
Documents carry version_status metadata; superseded material is filtered from normal retrieval unless the question is explicitly historical.
Answers should separate law, guidance, Q&A, templates and agency practice, then flag conflicts or gaps instead of smoothing them over.
Reviewed authority coverage
CMDh (5)EDQM (1)EMA (21)eSubmission (5)EUR-Lex (8)European Commission (11)HPRA (1)ICH (76)
Reviewed source types
Guidance (119)Legislation (8)Template (1)
Reviewed EU/EEA documents
Directive 2001/83/EC — Community code relating to medicinal products for human uselawcurrentRegulation (EC) No 726/2004 — Community authorisation and supervision of medicinal products; establishing the EMAlawcurrentConsolidated Regulation (EC) No 1234/2008 — Examination of variations to the terms of marketing authorisations (01 January 2025)lawcurrentRegulation (EU) No 536/2014 — Clinical trials on medicinal products for human uselawcurrentRegulation (EC) No 1901/2006 — Medicinal products for paediatric uselawcurrentRegulation (EC) No 141/2000 — Orphan medicinal productslawcurrentRegulation (EU) 2017/745 — Medical devices (relevant for drug-device combinations)lawcurrentCommission Guidelines (C/2025/5045) on the details of the various categories of variationsguidancecurrentEudraLex Volume 2A Chapter 1 — Marketing authorisation procedures (Notice to Applicants)guidancecurrentEudraLex Volume 2B — Presentation and content of the dossier (CTD)guidancecurrentEudraLex Volume 4 — EU GMP Part I, Chapter 1: Pharmaceutical Quality SystemguidancecurrentEudraLex Volume 4 — EU GMP Part II: Basic requirements for active substancesguidancecurrentEMA pre-authorisation procedural advice (centralised procedure)guidancecurrentEMA post-authorisation procedural advice (centralised procedure)guidancecurrentEMA QRD product information annotated template (human, v10.4)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Annex I: Definitions (Rev 5)guidancecurrentCMDh Best Practice Guide Chapter 5 — Processing of Type II variations in MRPguidancecurrentCMDh explanatory notes on the variation application formguidancecurrentEDQM — Content of the dossier for chemical purity and microbiological quality (PA/PH/CEP (04) 1, 7R)guidancecurrentHarmonised Technical Guidance for eCTD Submissions in the EUguidancecurrentEU Module 1 eCTD specification and guidanceguidancecurrentElectronic Application Form (eAF) — practical user guide (human & veterinary)guidancecurrentSPOR — Organisation Management Service (OMS) operating modelguidancecurrentConsolidated Commission Delegated Regulation (EU) 2016/161 — safety features on the packaging of medicinal products for human use, incl. Annex I and Annex II (01 January 2022)lawcurrentCMDh annotated QRD template for MRP/DCP (CMDh/201/2005 Rev.12.1)guidancecurrentQRD convention to be followed for the EMA QRD templates (EMA/62470/2007)guidancecurrentEudraLex Volume 2C — Guideline on the readability of the labelling and package leaflet of medicinal products for human use (Revision 1)guidancecurrentOperational procedure on the handling of the consultation with target patient groups (user testing) for package leaflets of centrally authorised productsguidancecurrentEudraLex Volume 2C — Guideline on excipients in the labelling and package leaflet of medicinal products for human use (SANTE-2017-11668)guidancecurrentChecking process of mock-ups and specimens of outer/immediate labelling and package leaflets of human medicinal products in the centralised procedureguidancecurrentAnnex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (EMA/CHMP/302620/2017 Rev.2)guidancecurrentEudraLex Volume 2C — Guideline on the packaging information of medicinal products for human use authorised by the UnionguidancecurrentCMDh Best Practice Guide on multilingual packaging (CMDh/413/2019 Rev.5)guidancecurrentHPRA Guide to Labels and Leaflets of Human Medicines (AUT-G0034 v26)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module I: Pharmacovigilance systems and their quality systemsguidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module II: Pharmacovigilance system master file (Rev 2)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module III: Pharmacovigilance inspectionsguidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module IV: Pharmacovigilance audits (Rev 1)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module V: Risk management systems (Rev 2)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module VI: Collection, management and submission of reports of suspected adverse reactions (Rev 2)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module VII: Periodic safety update reportguidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module VIII: Post-authorisation safety studies (Rev 3)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module IX: Signal management (Rev 1)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module X: Additional monitoringguidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module XV: Safety communication (Rev 1)guidancecurrentEMA Good Pharmacovigilance Practices (GVP) — Module XVI: Risk minimisation measures (Rev 3)guidancecurrentEudraLex Volume 2A Chapter 2 — Mutual recognition (Notice to Applicants, Feb 2007)guidancecurrentEudraLex Volume 2A Chapter 3 — Union referral procedures (Notice to Applicants)guidancecurrentEudraLex Volume 2A Chapter 6 — Community marketing authorisation (Notice to Applicants, Nov 2005)guidancecurrentEU eCTD 3.2.2 — EU Module 1 Validation Criteria v8.2 (mandatory from 1 December 2025)guidancecurrentEU eCTD 3.2.2 — EU Module 1 Validation Criteria v8.2 release notesguidancecurrentCMDh Blue box requirements (CMDh/258/2012 Rev.26) — one document covering 31 territoriesguidancecurrent
Reviewed ICH guidelines (international, not EU-specific)
ICH Q1A(R2) — Stability testing of new drug substances and productsguidancecurrentICH Q2(R2) — Validation of analytical proceduresguidancecurrentICH Q8(R2) — Pharmaceutical developmentguidancecurrentICH Q9(R1) — Quality risk managementguidancecurrentICH Q10 — Pharmaceutical quality systemguidancecurrentICH Q11 — Development and manufacture of drug substancesguidancecurrentICH Q12 — Technical and regulatory considerations for pharmaceutical product lifecycle managementguidancecurrentICH M4 — Organisation of the Common Technical Document (CTD)guidancecurrentICH E6(R3) — Good Clinical Practice (GCP)guidancecurrentICH E2E — Pharmacovigilance planningguidancecurrentICH Q12 Annexes — Pharmaceutical product lifecycle management (annexes)guidancecurrentICH Q14 — Analytical procedure developmentguidancecurrentICH M4Q(R1) — CTD Module 2/3: QualityguidancecurrentICH M4S(R2) — CTD Module 2/4: Safety (nonclinical)guidancecurrentICH M4E(R2) — CTD Module 2/5: Efficacy (clinical)guidancecurrentICH Q1B — Photostability testing of new drug substances and productsguidancecurrentICH Q1C — Stability testing for new dosage formsguidancecurrentICH Q1D — Bracketing and matrixing designs for stability testingguidancecurrentICH Q1E — Evaluation of stability dataguidancecurrentICH Q3A(R2) — Impurities in new drug substancesguidancecurrentICH Q3B(R2) — Impurities in new drug productsguidancecurrentICH Q3C(R9) — Impurities: guideline for residual solventsguidancecurrentICH Q3D(R2) — Guideline for elemental impuritiesguidancecurrentICH Q4B(R1) — Evaluation and recommendation of pharmacopoeial texts for use in the ICH regionsguidancecurrentICH Q5A(R2) — Viral safety evaluation of biotechnology products derived from cell lines of human or animal originguidancecurrentICH Q5B — Analysis of the expression construct in cells used for production of r-DNA derived protein productsguidancecurrentICH Q5C — Stability testing of biotechnological/biological productsguidancecurrentICH Q5D — Derivation and characterisation of cell substrates used for production of biotechnological/biological productsguidancecurrentICH Q5E — Comparability of biotechnological/biological products subject to changes in their manufacturing processguidancecurrentICH Q6A — Specifications: test procedures and acceptance criteria for new drug substances and new drug products (chemical substances)guidancecurrentICH Q6B — Specifications: test procedures and acceptance criteria for biotechnological/biological productsguidancecurrentICH Q7 — Good manufacturing practice guide for active pharmaceutical ingredientsguidancecurrentICH Q13 — Continuous manufacturing of drug substances and drug productsguidancecurrentICH S1A — Need for carcinogenicity studies of pharmaceuticalsguidancecurrentICH S1B(R1) — Testing for carcinogenicity of pharmaceuticalsguidancecurrentICH S1C(R2) — Dose selection for carcinogenicity studies of pharmaceuticalsguidancecurrentICH S2(R1) — Genotoxicity testing and data interpretation for pharmaceuticals intended for human useguidancecurrentICH S3A — Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studiesguidancecurrentICH S3B — Pharmacokinetics: guidance for repeated dose tissue distribution studiesguidancecurrentICH S4 — Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing)guidancecurrentICH S5(R3) — Detection of reproductive and developmental toxicity for human pharmaceuticalsguidancecurrentICH S6(R1) — Preclinical safety evaluation of biotechnology-derived pharmaceuticalsguidancecurrentICH S7A — Safety pharmacology studies for human pharmaceuticalsguidancecurrentICH S7B — Nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation)guidancecurrentICH S8 — Immunotoxicity studies for human pharmaceuticalsguidancecurrentICH S9 — Nonclinical evaluation for anticancer pharmaceuticalsguidancecurrentICH S10 — Photosafety evaluation of pharmaceuticalsguidancecurrentICH S11 — Nonclinical safety testing in support of development of paediatric pharmaceuticalsguidancecurrentICH S12 — Nonclinical biodistribution considerations for gene therapy productsguidancecurrentICH E1 — The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditionsguidancecurrentICH E2A — Clinical safety data management: definitions and standards for expedited reportingguidancecurrentICH E2B(R3) — Electronic transmission of individual case safety reports (ICSRs)guidancecurrentICH E2C(R2) — Periodic benefit-risk evaluation report (PBRER)guidancecurrentICH E2D — Post-approval safety data: definitions and standards for expedited reportingguidancecurrentICH E2F — Development safety update report (DSUR)guidancecurrentICH E3 — Structure and content of clinical study reportsguidancecurrentICH E4 — Dose-response information to support drug registrationguidancecurrentICH E5(R1) — Ethnic factors in the acceptability of foreign clinical dataguidancecurrentICH E7 — Studies in support of special populations: geriatricsguidancecurrentICH E8(R1) — General considerations for clinical studiesguidancecurrentICH E9(R1) — Statistical principles for clinical trials (with estimands and sensitivity analysis addendum)guidancecurrentICH E10 — Choice of control group and related issues in clinical trialsguidancecurrentICH E11(R1) — Clinical investigation of medicinal products in the paediatric populationguidancecurrentICH E11A — Paediatric extrapolationguidancecurrentICH E14 — Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugsguidancecurrentICH E15 — Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categoriesguidancecurrentICH E16 — Biomarkers related to drug or biotechnology product development: context, structure and format of qualification submissionsguidancecurrentICH E17 — General principles for planning and design of multi-regional clinical trialsguidancecurrentICH E18 — Genomic sampling and management of genomic dataguidancecurrentICH E19 — Optimisation of safety data collectionguidancecurrentICH M3(R2) — Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticalsguidancecurrentICH M7(R2) — Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic riskguidancecurrentICH M9 — Biopharmaceutics Classification System-based biowaiversguidancecurrentICH M10 — Bioanalytical method validation and study sample analysisguidancecurrentICH M12 — Drug interaction studiesguidancecurrentICH M13A — Bioequivalence for immediate-release solid oral dosage formsguidancecurrent
Known gaps
These documents are catalogued in the manifest but not yet reviewed, even where the same authority has reviewed documents above. For questions that depend on them, the assistant should flag the gap instead of presenting an unsupported answer.
EudraLex Volume 1 — EU pharmaceutical legislation (human medicines)CMDh Questions & Answers (general)BfArM guidance (Germany)Paul-Ehrlich-Institut guidance (Germany, biologicals/vaccines)ANSM guidance (France)AEMPS guidance (Spain)AIFA guidance (Italy)HPRA guidance (Ireland)MEB/CBG guidance (Netherlands)Fimea guidance (Finland)Danish Medicines Agency guidance (Denmark)