Consultation Deadlines

24th January 2019
31st January 2019
4th February 2019
6th February 2019
11th February 2019
15th February 2019
17th February 2019
21st March 2019
14th April 2019
15th May 2019
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
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.

30th September 2019
31st October 2019