EMA health threats plan - Annex 1: Acceleration of regulatory procedures during public health emergencies

EMA health threats plan

Dates of 2025 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests

Dates of 2026 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests

Human medicines European public assessment report (EPAR): Ristfor, sitagliptin,metformin hydrochloride, Date of authorisation: 15/03/2010, Revision: 31, Status: Authorised

EMEA-001489-PIP02-19

EMEA-001489-PIP01-13-M02

EMEA-002821-PIP01-20

Opinion/decision on a Paediatric investigation plan (PIP): Spevigo, spesolimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0157/2024

Human medicines European public assessment report (EPAR): Awiqli, insulin icodec, Date of authorisation: 17/05/2024, Revision: 2, Status: Authorised