Regulatory Affairs
EMA / EC CONSULTATIONS
Preparedness of medicines' clinical trials in paediatrics - Recommendations by the Enpr-EMA working group on trial preparedness - EMA/56009/2019 Corr. 1
EU Commission's Inception Impact Assessment for Revision of the EMA fee system - Annex
Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses - EMA/CHMP/SAWP/291384/2019
ICH guideline E19 on optimisation of safety data collection (Step 2) - EMA/CHMP/ICH/173706/2019
ICH guideline E8(R1) on general considerations for clinical studies - Step 2b - EMA/CHMP/ICH/544570/1998
Draft qualification opinion of Multiple Sclerosis clinical outcome assessment (MSCOA) - EMA/CHMP/SAWP/336445/2019
Reflection paper on the qualification of non-genotoxic impurities - EMA/CHMP/SWP/545588/2017
ICH guideline M10 on bioanalytical method validation - EMA/CHMP/ICH/172948/2019
Electronic Product Information for Human Medicines in the EU - Draft Key Principles
Draft questions and answers on Data Monitoring Committees issues - EMA/492010/2018
Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3 - EMA/844951/2018
Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations - EMA/763513/2018
Guideline on the environmental risk assessment of medicinal products for human use - EMEA/CHMP/SWP/4447/00 Rev. 1
Targeted consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another - ENTR/6283/00 Rev 5
Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man - EMA/CHMP/755489/2018
Good practice guidance for communication on medicines' availability issues - EMA/632473/2018
ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines - Step 2b - EMA/CHMP/ICH/616110/2019
eSource Direct Capture (DDC) qualification opinion - EMA/282576/2018
Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3 - CHMP/EWP/566/98
Response to EU Ombudsman - Strategic inquiry into pre-submission activities organised by the European Medicines Agency - OI/7/2017/KR
ICH guideline M9 on biopharmaceutics classification system based biowaivers - EMA/CHMP/ICH/493213/2018
ICH Guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management Step 2b - EMA/CHMP/ICH/804273/2017
Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - EMA/PDCO/362462/2016
Guideline on the Use of Minimal Residual Disease as a Clinical Endpoint in Multiple Myeloma Studies - EMA/CHMP/459559/2018
Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version - EMA/CHMP/187859/2017
Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - EMA/CHMP/75653/2018
Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice - EMA/202679/2018
Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - CPMP/EWP/1080/00 Rev. 2
Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population - EMA/CHMP/535116/2016
Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement - EMA/189939/2018
Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - EMA/CHMP/257022/2017
Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development - EMA/CHMP/138502/2017
Annex 1 on manufacturing of sterile medicinal products - Revision
EFPIA, AESGP and MfE response to EMA consultation on Initiatives for electronic EU product information - (Annex 1); (Annex 2)
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials - EMA/CHMP/ICH/436221/2017
Reflection paper on the pharmaceutical development of medicines for use in the older population (First version) - EMA/CHMP/QWP/292439/2017
Reflection paper on the use of extrapolation in the development of medicines for paediatrics - EMA/199678/2016
CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NPAs - CMDh/367/2017
Roadmap on the Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations)
Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle - EMA/CHMP/800914/2016
GVP Product- or Population-Specific Considerations IV: Paediatric population (EMA/572054/2016)
Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents - CPMP/EWP/239/95 Rev. 1
Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol – EMA/430909/2016
Concept paper on the revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population – EMA/CHMP/448599/2016
Draft guideline on good-clinical-practice compliance in relation to trials master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials – EMA/15975/2016
Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza (EMA/CHMP/EWP/808940/2016)
Draft guideline on multiplicity issues in clinical trials - EMA/CHMP/44762/2017
Concept paper on the need to revise Condition – Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man – EMA/CHMP/102314/2017
Concept paper on a revision of the guideline on the investigation of drug interactions – EMEA/CHMP/694687/2016
Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents – EMA/CHMP/267194/2016
Target stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use
EMA policy on access to documents - EMA/729522/2016
Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)
ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities) – questions and answers – EMA/CHMP/ICH/809509/2016
ICH E11 (R1) guideline on clinical investigation of medicinal products in the pediatric population - EMA/CPMP/ICH/2711/1999
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of depression– EMA/CHMP/183826/2016
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (EMA/CHMP/SWP/28367/07 Rev. 1)
Draft Regulation on GMP for IMPs
Implementing Directive on Principles and guideline on good manufacturing practices for medicinal products for human use
Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation - EMA/CHMP/458101/2016
Concept paper on reparation of a guideline on the evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infection - EMA/CHMP/360458/2016
Concept paper on the need for revision of the guideline on clinical investigation of medicinal product for the treatment of migraine - EMA/CHMP/179671/2016
Guideline on the development of new medicinal products for the treatment of ulcerative colitis - EMA/EWP/18463/2006 Rev. 1
Guideline on the development of new medicinal products for the treatment of Crohn's
Addendum to the 'guideline on the evaluation of medicinal products indicated for treatment of bacterial infections' to address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis - EMA/CHMP/EWP/14377/2008 Rev. 1
Concept paper on Good Manufacturing Practice and Marketing Authorisation Holders - EMA/582064/2016
Draft guideline on good pharmacovigilance practices (GVP) - Module IX and Addendum I
Draft guideline on evaluation of anticancer medicinal products in man - EMA/CHMP/205/95 Rev. 5
EFPIA-EBE comments on good pharmacogenomics practice - EMA/CHMP/268544/2016
Draft implementation strategy of ICH Q3D guideline EMA/404489/2016
Summary of Clinical Trial Results for Laypersons
Risk proportionate approaches in clinical trials
Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
Guideline on good pharmacovigilance practices (GVP) - Module XV (Rev 1) - EMA/118465/2012
AESGP EFPIA and EGA Response to NIVEL Study Reports PIL-S and PIL-BOX - January 2016
Draft guideline on manufacture of the finished dosage form - EMA/CHMP/QWP/245074/2015
Annex 17 on Real Time Release Testing
Draft guideline on the chemistry of active substances - EMA/CHMP/QWP/96664/2015
Draft guideline on the processing of renewals in the centralised procedure - EMA/CHMP/2990/00 Rev. 5
Concept paper on new guidance for importers of medicinal products - EMA/2382299/2015
EU Telematics Strategy and Implementation Roadmap 2015-2017 - EMA/201512/2015
Good practice guide on risk minimisation and prevention of medication errors - EMA/606103/2014
Annual Regulatory GMP/GDP Inspection Survey
Since 2003 EFPIA is being engaged in surveying member companies to map the level of Good Manufacturing Practice (GMP) inspections performed at each of their manufacturing sites. Since the last few years, the survey has included Good Distribution Practice (GDP) inspections and ISO-certifications as well.
Download the Annual Regulatory GMP/GDP Inspection Survey 2018 data
Download the Annual Regulatory GMP/GDP Inspection Survey 2017 data
Download the Annual Regulatory GMP/GDP Inspection Survey 2016 data
Position Papers
- EFPIA CDEG position paper on the use of Form FDA 1572 for clinical trials performed outside the USA get_app
- Reflection paper on regulatory uncertainties for co-packaged and cross labelled drug-device combinations under MDR get_app
- EFPIA Industry Perspective about QMS for Drug-Device Combination Products get_app
- Request for Optimising the GMP paper-based Inspection Process by Regulatory Authorities get_app
- Post-approval Changes for Biologics in Latin American Markets get_app
- Optimising Post Approval Change Management for Safety Labelling Updates in the Middle East Region get_app
- EFPIA Position Paper on Halal requirements for Pharmaceuticals and Biologicals in ASEAN get_app
- EFPIA IREG Points to consider on Orphan Medicinal Products in Emerging Markets get_app
- EBE-EFPIA Reflection Paper An Industry Perspective on Article 117 of the EU Medical Devices Regulation and the Impact on how Medicines are Assessed get_app
- EFPIA Position Paper on non-harmonised requirements in local pharmacopoeias get_app
- Roadmap evaluation comments to EU commision_20171221 get_app
- Optimising Post-Approval Change Management for Timely Access to Medicinal Worldwide (2017) get_app
- Position paper - A Concept for Harmonised Reporting of Inspections (2015) get_app
- Position paper on Rationale for Removing Abnormal Toxicity Testing (2015) get_app
- CTAs: Redundant QC testing of pharmaceutical products - Russia network (March 2013) get_app
- A concept for harmonized reporting of inspections (May 2015) get_app
- LatAm network stability position paper (May 2015) get_app
Deletion of test for abnormal toxicity from European pharmacopoeiaOn 3 April 2017, the European Pharmacopoeia Commission asked for public feedback on its proposal to remove the requirements for a test on abnormal toxicity (ATT) from 49 monographs of the European Pharmacopeia. The EFPIA response can be accessed here.