Consultation Deadlines

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15th December 2018
FDA guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation.”
16th December 2018
EMA Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate – Revision 1: consultation open.
17th December 2018
FDA draft guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.”

FDA draft guidance for industry entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.”

FDA draft guidance for industry entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.”

18th December 2018
EMA Scientific guideline: Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Step 2b – First version, draft: consultation open.
21st December 2018
EMA Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open.
24th December 2018
FDA draft guidance for industry and review staff entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.”

FDA draft guidance for industry entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.”

31st December 2018
EMA Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV – First version, draft: consultation open.
2nd January 2019
FDA draft guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.”
4th January 2019
European Commission public consultation on an evaluation of the legislation on medicines for children and rare diseases (medicines for special populations).
7th January 2019
FDA draft guidance for industry entitled “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.”
14th January 2019
FDA draft guidance for industry entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.”
15th January 2019
EMA Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open.
24th January 2019
FDA draft guidance for industry entitled “Biopharmaceutics Classification System-Based Biowaivers.”
31st January 2019
EMA Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation, draft: consultation open.
4th February 2019
FDA draft guidance for industry entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.”
6th February 2019
EMA Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers – Step 2b – First version, draft: consultation open.
11th February 2019
FDA revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.”
15th February 2019
EMA Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) – Revision 1, draft: consultation open.
17th February 2019
EMA Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3, draft: consultation open.
15th May 2019
EMA Scientific guideline: Draft guideline on the quality of water for pharmaceutical use, draft: consultation open.
30th June 2019
EMA Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, draft: consultation open.

EMA Scientific guideline: 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), draft: consultation open.

EMA Scientific guideline: Guideline on the non-clinical requirements for radiopharmaceuticals, draft: consultation open.

EMA Scientific guideline: Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease, draft: consultation open.

EMA Scientific guideline: Guideline on clinical investigation of recombinant and human plasma-derived factor IX products – Revision 2, draft: consultation open.

EMA Scientific guideline: Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products – Revision 3, draft: consultation open.

EMA Scientific guideline: Guideline on the environmental risk assessment of medicinal products for human use – Revision 1, draft: consultation open.

31st July 2019
EMA Scientific guideline: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open.

EMA Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open.

EMA Scientific guideline: Draft questions and answers on Data Monitoring Committees issues, draft: consultation open.

31st August 2019
EMA Scientific guideline: Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector-borne diseases in dogs and cats, draft: consultation open.

EMA Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances – Revision 1, draft: consultation open.

EMA Scientific guideline: Reflection paper on resistance in ectoparasites, draft: consultation open.

EMA Scientific guideline: Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), draft: consultation open.

EMA Scientific guideline: Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products, draft: consultation open.

30th September 2019
EMA Scientific guideline: Reflection paper on the qualification of non-genotoxic impurities, draft: consultation open.
31st October 2019
EMA Scientific guideline: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products – Revision 3, draft: consultation open.