Regulatory Blog

Access to accurate, up-to-date information about medicines is important for healthcare professionals, patients, and anyone seeking to understand how a medicine should be used safely. Product information provides details about the use of medicines, their properties, and the scientific basis for marketing authorisations. The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance, Find product information about medicines, to explain how users can acc

Access to accurate and up-to-date medicinal product information is essential for the safe prescribing, dispensing, and use of medicines. Healthcare professionals rely on authorised product information to make informed clinical decisions, while patients depend on clear instructions to use medicines safely and effectively. Providing easy access to approved regulatory information also promotes transparency throughout a medicine's lifecycle. The Medicines and Healthcare products

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance on " Product Information for Human Medicinal...

The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...

The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human". The...

Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...

Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...