Consultation Deadlines

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28th April 2019
European Commission 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.
29th April 2019
FDA draft guidance for industry entitled “Assessing the Effects of Food on Drugs in INDs and NDAs—Clinical Pharmacology Considerations.”
7th May 2019
FDA draft guidance for industry entitled “Principles of Premarket Pathways for Combination Products.”

FDA draft guidance for industry entitled “Nonproprietary Naming of Biological Products: Update.”

13th May 2019
FDA draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.”

FDA draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.”

FDA draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.”

FDA draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.”

14th May 2019
FDA draft guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.”
15th May 2019
EMA Scientific guideline: Draft guideline on the quality of water for pharmaceutical use, draft: consultation open.
24th May 2019
FDA draft guidance for industry entitled “Rare Diseases: Natural History Studies for Drug Development.”
28th May 2019
FDA draft guidance for industry entitled “Bioavailability Studies Submitted in NDAs or INDs—General Considerations.”

FDA draft guidance for industry entitled “Quality Considerations for Continuous Manufacturing.”

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.

EMA Scientific guideline: Guideline on quality and equivalence of topical products, draft: consultation open.

EMA Scientific guideline: Concept paper on a guideline for allergen products development in moderate to low-sized study populations, draft: consultation open.

EMA Regulatory Science to 2025 – Strategic Reflection, draft: consultation open.

EMA Scientific guideline: Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections – Revision 3, 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.

EMA, HMA and European Commission (EC) public consultation on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will be developed and used in the European Union.

1st August 2019
EMA Scientific guideline: Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, draft: consultation open.
8th August 2019
EMA Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of gout, 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.

EMA Scientific guideline: Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, draft: consultation open.

EMA Scientific guideline: Revised guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open.

EMA Scientific guideline: Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats, draft: consultation open.

EMA Scientific guideline: Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances, draft: consultation open.

1st September 2019
EMA Scientific guideline: Draft ICH guideline M10 on bioanalytical method validation – Step 2b, draft: consultation open.
29th September 2019
EMA Scientific guideline: Draft ICH guideline E19 on optimisation of safety data collection – Step 2b, 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.