Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
To reply to a consultation, please use the form for comments (which is also linked within each consultation document):
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see:
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ICH: E 8 (R1): General considerations for clinical studies - Step 2b (PDF/441.18 KB)
Reference numberEMA/CHMP/ICH/544570/1998StatusDraft: consultation openFirst published10/05/2019Consultation dates10/05/2019 to 30/09/2019Email address for submissionsSummaryThe ICH guideline 'General considerations for clinical studies' is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities, provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct. It provides an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives.
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Draft ICH guideline E19 on optimisation of safety data collection - Step 2b (PDF/251.51 KB)
Reference numberEMA/CHMP/ICH/173706/2019StatusDraft: consultation openFirst published29/03/2019Consultation dates29/03/2019 to 29/09/2019Email address for submissionsSummaryThis guideline explores under what circumstances a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies would be appropriate and how to implement such an approach. This approach could reduce the burden to patients which can serve as a disincentive to participation in clinical research, while recognising that protection of patient welfare during medicine development is of critical importance. The aim is to enable a larger number of informative clinical studies to be carried out with greater efficiency and greater global participation in studies, for the benefit of public health.
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Draft ICH guideline M10 on bioanalytical method validation - Step 2b (PDF/978.96 KB)
Reference numberEMA/CHMP/ICH/172948/2019StatusDraft: consultation openFirst published14/03/2019Consultation dates14/03/2019 to 01/09/2019Email address for submissions
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Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance (PDF/124.21 KB)
Reference numberEMA/CHMP/35552/2019StatusDraft: consultation openFirst published08/03/2019Consultation dates08/03/2019 to 30/06/2019Email address for submissions
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Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’ (PDF/87.33 KB)
Reference numberEMA/HMPC/37920/2019StatusDraft: consultation openFirst published28/02/2019Consultation dates28/02/2019 to 31/08/2019Email address for submissions
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Call for scientific data for use in HMPC assessment work on ‘Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) (EMA/HMPC/893108/2011)’ (PDF/76.52 KB)
Reference numberEMA/HMPC/39600/2019StatusDraft: consultation openFirst published28/02/2019Consultation dates28/02/2019 to 31/08/2019Email address for submissions
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Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials (PDF/559.18 KB)
Reference numberEMA/CAT/852602/2018StatusDraft: consultation openFirst published21/02/2019Consultation dates21/02/2019 to 01/08/2019Email address for submissions
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Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance (PDF/124.51 KB)
Reference numberEMA/CHMP/802679/2018StatusDraft: consultation openFirst published08/02/2019Consultation dates08/02/2019 to 30/06/2019Email address for submissions
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Draft guideline on clinical investigation of medicinal products for the treatment of gout (PDF/299.63 KB)
Reference numberEMA/CHMP/774470/2018StatusDraft: consultation openFirst published08/02/2019Consultation dates08/02/2019 to 08/08/2019Email address for submissions
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Draft alectinib hard capsule 150 mg product-specific bioequivalence guidance (PDF/124.28 KB)
Reference numberEMA/CHMP/790261/2018StatusDraft: consultation openFirst published08/02/2019Consultation dates08/02/2019 to 30/06/2019Email address for submissions
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Electronic product information for human medicines in the European Union – draft key principles (PDF/519.15 KB)
Reference numberEMA/849614/2018StatusDraft: consultation openFirst published31/01/2019Consultation dates31/01/2019 to 31/07/2019SummaryA medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about safe use. The development of electronic product information (ePI) is intended to improve access to up-to-date product information when and where it is needed. The European Medicines Agency, in collaboration with Heads of Medicines Agencies and the European Commission, has developed some key principles through stakeholder consultations to guide future development of ePI for medicines in the EU.
We wish to ask the public whether they agree with the key principles we have identified and whether there is any additional topic that should be reflected. Comments should be submitted via an online form.
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Procedure on management of proposals submitted by Interested Parties for European Union List Entries or European Union herbal monographs - Revision 2 (PDF/190.21 KB)
Reference numberEMEA/HMPC/328575/2007 Rev.2StatusDraft: consultation openFirst published30/01/2019Consultation dates30/01/2019 to 30/07/2019Email address for submissions
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Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3 (PDF/467.27 KB)
Reference numberEMA/844951/2018StatusDraft: consultation openFirst published14/01/2019Consultation dates14/01/2019 to 31/07/2019Email address for submissionsSummaryThis revised draft guideline describes how to carry out studies to demonstrate the benefits and risks of antibiotics, with guidance on study design for specific indications. The draft revision reflects the outcome of cooperation between EMA and international partner regulators to align data requirements as much as possible in Europe, the United States and Japan. In addition, it offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need, in accordance with experience gained from previous regulatory decisions. Specific advice has also been added with regards to regulatory requirements in the European Union to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhoea.
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Concept paper on a guideline for allergen products development in moderate to low-sized study populations (PDF/100.03 KB)
Reference numberEMA/CHMP/251023/2018StatusDraft: consultation openFirst published20/12/2018Consultation dates21/12/2018 to 30/06/2019Email address for submissions
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Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (PDF/244.96 KB)
Reference numberEMA/CVMP/EWP/755916/2016StatusDraft: consultation openFirst published19/12/2018Consultation dates19/12/2018 to 31/08/2019Email address for submissionsSummaryThis guideline provides specific guidance in respect to the documentation required to demonstrate the efficacy of veterinary medicinal products (VMPs) generally developed for the prevention or reduction of clinical signs of coccidiosis, and the reduction of oocyst shedding. The previous NtA guideline on anticoccidial products (7AE15a) was limited to poultry. This guideline covers a wider range of mammalian and avian target species, containing now general data requirements for all target species, as well as specific requirements for poultry, ruminants, dogs and cats, pigs and rabbits.
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EMA Regulatory Science to 2025 - Strategic reflection (PDF/3.66 MB)
StatusDraft: consultation openFirst published19/12/2018Consultation dates19/12/2018 to 30/06/2019SummaryThe Regulatory Science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines development that we together with the Commission and NCAs experts have identified in a thorough process of mapping and selection. Now we want to hear from our stakeholders whether they consider this strategy is ambitious enough.”
Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.
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Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Revision 1 (PDF/277.74 KB)
Reference numberEMA/CVMP/IWP/170689/2016StatusDraft: consultation openFirst published19/12/2018Consultation dates19/12/2018 to 31/08/2019Email address for submissionsSummaryThis Guideline lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for treatment or specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic diseases in horses, dogs and cats. In addition, guidance is given for the clinical testing regarding safety and efficacy of the products.
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Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2 (PDF/330.74 KB)
Reference numberEMA/CVMP/SWP/66781/2005 Rev. 2StatusDraft: consultation openFirst published18/12/2018Consultation dates18/12/2018 to 31/08/2019Email address for submissionsSummaryThis guideline updates the CVMP Guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species/ limited market (EMEA/CVMP/SWP/66781/2005 Rev. 1).
In order to stimulate the research, development and innovation of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals and a guideline for immunologicals. These guidelines are intended to reduce data requirements where possible for products classified as MUMS/limited market while still providing assurance of appropriate quality, safety and efficacy and complying with the legislation in place and leading to an overall positive benefit-risk balance for the product.
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Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance (PDF/78.11 KB)
Reference numberEMA/CHMP/790333/2018StatusDraft: consultation openFirst published17/12/2018Consultation dates21/12/2018 to 30/06/2019Email address for submissions
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Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance (PDF/75.94 KB)
Reference numberEMA/CHMP/802491/2018StatusDraft: consultation openFirst published17/12/2018Consultation dates21/12/2018 to 30/06/2019Email address for submissionsSummaryThis document provides product-specific guidance on the demonstration of the bioequivalence of ezetimibe tablet 10 mg.
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Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (PDF/147.5 KB)
Reference numberEMA/CVMP/QWP/153641/2018StatusDraft: consultation openFirst published17/12/2018Consultation dates17/12/2018 to 31/08/2019Email address for submissionsSummaryAs no guidance is currently available for marketing authorisation holders, active substance, medicinal product and excipient manufacturers for veterinary medicinal products, the purpose of this reflection paper is to provide information on how such risk management may be conducted for elemental impurities in products authorised or to be authorised in the European Union. It also highlights the expectations of regulators regarding the data to be submitted in the product dossier for those risk managements/assessments. In accordance with European Pharmacopoeia General Monograph 2619, the responsibility for the conduct of the risk management rests with the medicinal product manufacturer.
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Draft guideline on quality and equivalence of topical products (PDF/256.86 KB)
Reference numberCHMP/QWP/708282/2018StatusDraft: consultation openFirst published14/12/2018Consultation dates14/12/2018 to 30/06/2019Email address for submissionsSummaryThe guideline relates to locally applied and locally acting medicinal products for cutaneous use and is also relevant for other medicines e.g. preparations for auricular or ocular use. Specific guidance is provided:
- On the quality of topical products not covered by other guidelines.
- On equivalence testing of topical products in lieu of therapeutic equivalence clinical trials.
Note
The equivalence guidance is applicable to certain cases of demonstration of equivalence of a new topical medicinal product with an existing medicinal product.
As common knowledge in the field is currently being built, the draft guideline is published for public consultation to stimulate discussion. Comprehensive feedback would be welcome and as a result further elaboration of the equivalence guidance should be expected. In the meantime requests for scientific advice on specific recommendations or on clinical development are strongly encouraged.
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Draft guideline on the environmental risk assessment of medicinal products for human use - Revision 1 (PDF/697.81 KB)
Reference numberEMEA/CHMP/SWP/4447/00 Rev. 1StatusDraft: consultation openFirst published30/11/2018Consultation dates01/12/2018 to 30/11/2019Email address for submissionsSummaryThis document describes the assessment of potential environmental risks of human medicinal products. Read together with Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use.
This guideline replaces ‘Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2)’.
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Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3 (PDF/184.23 KB)
Reference numberEMA/CHMP/BPWP/1625/1999 rev. 3StatusDraft: consultation openFirst published30/11/2018Consultation dates03/12/2018 to 30/06/2019
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Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2 (PDF/574.17 KB)
Reference numberEMA/CHMP/BPWP/144552/2009 rev. 2 Corr.1StatusDraft: consultation openFirst published30/11/2018Last updated19/12/2018Consultation dates03/12/2018 to 30/06/2019
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Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (PDF/191.08 KB)
Reference numberEMA/CHMP/763438/2017StatusDraft: consultation openFirst published23/11/2018Consultation dates23/11/2018 to 30/06/2019Email address for submissionsSummaryPaediatric Addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
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Reflection paper on the qualification of non-genotoxic impurities (PDF/196.96 KB)
Reference numberEMA/CHMP/SWP/545588/2017StatusDraft: consultation openFirst published23/11/2018Consultation dates23/11/2018 to 30/09/2019Email address for submissions
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Draft guideline on the non-clinical requirements for radiopharmaceuticals - First version (PDF/165.08 KB)
Reference numberEMA/CHMP/SWP/686140/2018StatusDraft: consultation openFirst published22/11/2018Consultation dates22/11/2018 to 30/06/2019Email address for submissionsSummaryThis new guideline is intended to provide guidance on the required non-clinical data to support clinical development and approval of radiopharmaceuticals. The document is intended to complement currently available guidelines (such as ICH M3(R2), ICH S6(R1), ICH S9 or the EMA guideline on "strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products" and includes the different intended uses of radiopharmaceuticals including radiodiagnostics as well as radiotherapeutics. The new guideline is focusing on opportunities to targeted non-clinical programs according to specific development settings and product types and is not intended to duplicate guidance related to dosimetry.
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Draft reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products (PDF/963.64 KB)
Reference numberEMA/CVMP/ERA/632109/2014StatusDraft: consultation openFirst published21/11/2018Consultation dates21/11/2018 to 31/08/2019Email address for submissions
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Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) (PDF/422.33 KB)
Reference numberEMA/CHMP/299976/2018StatusDraft: consultation openFirst published19/11/2018Last updated12/12/2018Consultation dates19/11/2018 to 31/08/2019Email address for submissionsSummaryThe drafting of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) is intended in order to address and to avoid potential pitfalls in drug development.
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Draft information for the package leaflet regarding proline used as an excipient in medicinal products for human use (PDF/305.16 KB)
Reference numberEMA/CHMP/332530/2015StatusDraft: consultation openFirst published19/11/2018Consultation dates19/11/2018 to 31/05/2019Email address for submissions
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Draft information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use (PDF/500.53 KB)
Reference numberEMA/CHMP/190743/2016StatusDraft: consultation openFirst published19/11/2018Consultation dates19/11/2018 to 31/05/2019Email address for submissions
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Draft information for the package leaflet regarding lactose used as an excipient in medicinal products for human use (PDF/352.05 KB)
Reference numberEMA/CHMP/186428/2016StatusDraft: consultation openFirst published19/11/2018Consultation dates19/11/2018 to 31/05/2019Email address for submissions
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Draft information for the package leaflet regarding dextrans used as excipients in medicinal products for human use (PDF/241.77 KB)
Reference numberEMA/CHMP/187129/2016StatusDraft: consultation openFirst published19/11/2018Consultation dates19/11/2018 to 31/05/2019Email address for submissions
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CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 3 (PDF/359.26 KB)
Reference numberEMA/CHMP/BWP/303353/2010 Rev 3StatusDraft: consultation openFirst published16/11/2018Consultation dates18/10/2018 to 31/10/2019Email address for submissions
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Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CHMP/EWP/714/98 rev 1) (PDF/92.67 KB)
Reference numberEMA/CHMP/78339/2018StatusDraft: consultation openFirst published15/11/2018Consultation dates12/11/2018 to 30/06/2019Email address for submissions
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Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations (DOCX/264.45 KB)
Reference numberEMA/763513/2018StatusDraft: consultation openFirst published09/11/2018Consultation dates09/11/2018 to 30/06/2019
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Reflection paper on resistance in ectoparasites (PDF/308.67 KB)
Reference numberEMA/CVMP/EWP/310225/2014StatusDraft: consultation openFirst published21/09/2018Last updated21/09/2018Consultation dates21/02/2018 to 31/08/2019Email address for submissionsSummaryThe Committee adopted a new draft reflection paper on ectoparasitic resistance (EMA/CVMP/EWP/310225/2014) for a 11-month period of public consultation. The reflection paper aims to give an overview of the currently known resistance situation in ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms.
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Draft questions and answers on Data Monitoring Committees issues (PDF/105.13 KB)
Reference numberEMA/492010/2018StatusDraft: consultation openFirst published01/08/2018Last updated01/08/2018Consultation dates01/08/2018 to 31/07/2019Email address for submissionsSummaryThe aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee Guideline (Doc Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle as well as with regard to the responsibilities for implementing DMC decisions.
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Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (PDF/322.12 KB)
Reference numberEMA/CAT/GTWP/671639/2008 Rev. 1StatusDraft: consultation openFirst published31/07/2018Last updated31/07/2018Consultation dates31/07/2018 to 31/07/2019Email address for submissionsSummaryThis guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.
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Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats (PDF/181.1 KB)
Reference numberEMA/CVMP/EWP/278031/2015StatusDraft: consultation openFirst published27/07/2018Last updated27/07/2018Consultation dates27/07/2018 to 31/08/2019Email address for submissions
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Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury (PDF/177.01 KB)
Reference numberEMA/CHMP/171100/2018 Corr.StatusDraft: consultation openFirst published09/07/2018Last updated30/07/2018Consultation dates30/07/2018 to 01/08/2019Email address for submissionsSummaryThe concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.
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Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1 (PDF/153.63 KB)
Reference numberEMA/CVMP/383441/2005-Rev.1StatusDraft: consultation openFirst published30/04/2018Last updated21/09/2018Consultation dates30/04/2018 to 31/08/2019Email address for submissionsSummaryThe guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.
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Draft guideline on manufacture of the veterinary finished dosage form - Revision 1 (PDF/160.69 KB)
Reference numberEMA/CVMP/QWP/798401/2015StatusDraft: consultation openFirst published23/04/2018Last updated07/01/2019Consultation dates23/04/2018 to 31/08/2019Email address for submissions
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