The following documents for human and veterinary medicines were released for consultation:
date: 27/05/2024
- A revised ICH E2D(R1) guideline on ‘Post-approval safety data: definitions and standards for management and reporting of individual case safety reports’, updated on the use of new sources of post-approval safety information such as social media, market research and patient support programs; until 22 June 2024.
- A revised guideline on Good Agricultural and Collection Practice for starting materials of herbal origin, updated to consider advances such as indoor growing technologies, established practices and legal interpretations; until 15 July 2024 (herbal medicines).
- A draft guideline providing guidance on stability data to be generated to support a variation to a marketing authorisation for veterinary medicinal products; until 31 August 2024.
- A revised guideline on requirements for demonstrating therapeutic equivalence between orally inhaled products for asthma and chronic obstructive pulmonary disease, updated on conditions for accepting in vitro data for therapeutic equivalence, paediatric requirements and pharmacokinetics data extrapolation; until 30 October 2024.
- A revised guideline on the pharmaceutical quality of inhalation and nasal human medicinal products, updated to consolidate guidance previously provided in a questions & answers document, advances in the field and the medical device regulation; until 31 October 2024.