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

Guideline on quality and equivalence of topical products - CHMP/QWP/708282/2018

Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) – EMA/CHMP/299976/2018

Guideline on the quality of water for pharmaceutical use - EMA/CHMP/CVMP/496873/2018

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

Draft guideline on the clinical evaluation of direct acting antivirals for the treatment of chronic hepatitis - EMA/CHMP/EWP/30039/2008 Rev. 1

Concept paper on Good Manufacturing Practice and Marketing Authorisation Holders - EMA/582064/2016

Draft guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1 - EMA/EWP/4891/03

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - EMA/317855/2016

EFPIA-EBE comments on Public consultation on Commission Implementing Regulation (EU) on detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014

Questions and answers on production of water for injections by non-destillation methods - reverse osmosis and biofilms and control strategies - EMA/INS/GMP/489331/2016

Joint response AESGP & EFPIA & Medicines for Europe - Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use' - EMEA/CHMP/SWP/4447/00 corr 2

Draft concept paper on the need for revision of the Note for Guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder - EMA/CHMP/318360/2015

Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (CPMP/EWP/570/98) - EMA/CHMP/207892/2015

Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - EMA/CHMP/318360/2015

Draft guideline on good pharmacovigilance practices (GVP) - Module IX and Addendum I

Draft guideline on good pharmacovigilance practices (GVP) Module VI - Management and reporting of adverse reactions to medicinal products (Rev. 2) - EMA/873138/2011

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken - EMA/CHMP/CVMP/JEG-3Rs/677407/2015

Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials – EMA/CHMP/QWP/834816/2015

Guideline on the sterilisation of the medicinal products, active substance, excipient and primary container -EMA/CHMP/CVMP/QWP/BWP/850374/2015

Concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ - EMEA/CHMP/SWP/28367/07

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

Reflection paper on collecting and reporting information on off-label use in pharmacovigilance – EMA/293194/2016

Draft guideline on clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias - EMA/CHMP/539931/2014

Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - EMA/CHMP/392958/2015

Draft implementation strategy of ICH Q3D guideline EMA/404489/2016

Summary of Clinical Trial Results for Laypersons

Risk proportionate approaches in clinical trials

Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)

Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors

Guideline on good pharmacovigilance practices (GVP) - Module V - Risk management systems (Rev 2) / Integrated Template

Draft points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial pomulations - EMA/CHMP/778709/2015

Draft guideline on clinical development of medicinal products intended for the treatment of pain - EMA/CHMP/970057/2011

Criteria to be fulfilled by industry stakeholder organisations involved in European Medicines Agency (EMA) activities

Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - EMA/CHMP/594085/2015

EFPIA-EBE comments on GVP Considerations - Product- or Population-Specific Considerations II: Biological medicinal products - EMA/168402/2014

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 scientific guidance on post-authorisation efficacy studies - EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015

Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME) - EMA/CHMP/57760/2015

Draft guideline on manufacture of the finished dosage form - EMA/CHMP/QWP/245074/2015

Annex 17 on Real Time Release Testing

Public consultation on detailed arrangements for clinical trial inspection procedures including the qualification and training requirements for inspectors pursuant to Article 78(7) of Regulation (EU) No 536/2014

Commission Implementing Act on Principles and guidelines on good manufacturing practices for medicinal products for human use, pursuant to the first paragraph of Article 47 of Directive 2001/83/EC

Detailed Commission guidelines on good manufacturing practice for investigational medicinal products, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014

Commission Delegated Act on principles and guidelines on good manufacturing practices for investigational medicinal products for human use and inspection procedures

CMDh Strategy to 2020

Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis - CPMP/EWP/556/95 Rev. 2

Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure - EMA/CHMP/707532/2013

Draft guideline on clinical development of fixed combination medicinal products - EMA/CHMP/281825/2015

Draft questions and answers on sodium laurilsulfate in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ – EMA/CHMP/606830/2014

Draft qualification opinion on paediatric ulcerative colitis activity index (PUCAI) - EMA/CHMP/SAWP/485560/2015

Draft guideline on the chemistry of active substances - EMA/CHMP/QWP/96664/2015

Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 - EMA/CHMP/509951/2006 Rev. 1

Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to article 14(9) of regulation (EC) No 726/2004 - EMA/CHMP/697051/2014 Rev. 1

Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases - EMA/CHMP/50549/2015

Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' - EMA/CHMP/338679/2014

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

Concept paper on the development of a guideline on quality and equivalence of topical products - EMA/CHMP/QWP/558185/2014

Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substances (NAS) status of chemical substances - EMA/CHMP/QWP/104223/2015

Draft concept paper on the need to revise the "Guideline on the evaluation of anticancer medicinal products in man" in order to provide guidance on the reporting of safety data from clinical trials - EMA/130525/2015

European Union Medicines Agencies Network Strategy to 2020 – Working together to improve health – EMA/MB/151414/2015

Questions & Answers on ‘Guideline on the environmental risk assessment of medicinal products for human use’– EMA/CHMP/SWP/44609/2010 Rev. 1

Guideline on good pharmacovigilance practices (GVP) – Module XVI Addendum I – Educational materials – EMA/61341/2015 Draft

Draft concept paper on the need for revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials – EMA/CHMP/QWP/126334/2015

Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies – EMA/629967/2014

Concept paper on clinical investigation of medicinal products for the treatment of Axial Spondyloarthritis – EMA/CHMP/80184/2015

Opinion of the Paediatric Committee on the review of the list of class waivers – EMA/PDCO/630781/2012

Concept paper on annex 1 of the guidelines on good manufacturing practice - manufacture of sterile medicinal products - EMA/606103/2014

Questions and Answers on cyclodextrins in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use - EMA/CHMP/495747/2013

EU Telematics Strategy and Implementation Roadmap 2015-2017 - EMA/201512/2015

Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in chronic pulmonary disease -EMA/CHMP/SAWP/178465/2015

Good practice guide on risk minimisation and prevention of medication errors - EMA/606103/2014

Good practice guide on recording, coding, reporting and assessment of medication errors - EMA/762563/2014

Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation an prevention of medication errors - EMA/686009/2014

Draft guideline on clinical evaluation of medicinal products used in weight control – EMA/CHMP/311805/2014

Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome – EMA/CHMP/559636/2014

Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of ulcerative colitis – EMA/CHMP/327812/2014

Draft guideline on regulatory acceptance of 3R (Replacement, Reduction, Refinement) testing approaches – EMA/CHMP/CVMP/JEG-3Rs/450091/2012

Draft paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease (EMA/EWP/2284/99 Rev. 1) – EMA/CHMP/328077/2014

Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency – EMA/CHMP/355988/2014

Concept paper on good genomics biomarker practices- EMA/CHMP/PGWP/415990/2014

Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis – EMA/CHMP/239770/2014 Rev. 2

Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies – EMA/CHMP/292464/2014

Questions and Answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use - EMA/CHMP/704219/2013

Reflection paper on the use of cocrystals and other solid state forms of active substances in medicinal products - EMA/CHMP/CVMP/136250/2014

Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC) - EMA/161530/2014

Draft revision of EudraVigilance access policy for medicines for human use – EMA/759287/2009 Rev. 1

Draft guideline on non-clinical local tolerance testing of medicinal products – EMA/CHMP/SWP/2145/2000 Rev. 1

Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies – EMA/CHMP/151853/2014

Draft guideline on the investigation of subgroups in confirmatory clinical trials - EMA/CHMP/539146/2013

Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMA/161530/2014

Concept paper on the need for a single note for guidance on the chemistry of active substances - EMA/CHMP/QWP/752676/2013

Draft reflection paper on the wording of indication for medicinal products for treatment of type 2 diabetes – EMA/CHMP/50673/2014

Questions and Answers on Ethanol in the context of the revision of the guideline on Excipients in the label and package leaflet of medicinal products for human use (EMA/CHMP/507988/2013)

Questions and Answers on Benzyl alcohol in the context of the revision of the guideline on Excipients in the label and package leaflet of medicinal products for human use - (EMA/CHMP/508188/2013)

Questions and Answers on Benzoic acid and Benzoates in the context of the revision of the guideline on Excipients in the label and package leaflet of medicinal products for human use - (EMA/CHMP/508189/2013)

Draft European Union individual case safety report (ICSR) implementation guide – EMA/51938/2013

Concept Paper on the establishment of a guideline on the selection of sterilisation processes for drug products – EMA/CHMP/CVMP/QWP/128000/2014

Concept paper on review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – EMA/CHMP/CVMP/JEG-3Rs/704685/2012

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

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.

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