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Principle of Automatic Substitution by Biosimilars
Like generic medicines, biological medicines that are very similar to another biological medicine (biosimilars) are included in a list drawn up by the French National Agency for the Safety of Medicines and Health Products (ANSM), which specifies the reference biological medicine and the biosimilars belonging to each group. However, substitution in pharmacies is not automatic and is subject to stricter rules than for generics. In accordance with the legal provisions in force, physicians may decide...
February 27, 2024
2 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation...
The SoHO proposal introduces the procedure for obtaining an authorisation...
January 18, 2024
7 min read
HMA-EMA publish multi-annual AI workplan: further guidance...
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG)...
January 16, 2024
4 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation...
Legislative process On July 19, 2022, the European Commission...
January 10, 2024
6 min read
The Legal 500: Pharmaceutical Advertising Country Comparative Guide 2023
The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online....
December 18, 2023
1 min read
Decarbonising the life sciences sector: challenges and progress
In 2019, it was reported that if the global healthcare sector were a country, it would be the fifth largest...
December 12, 2023
6 min read
AI in healthcare: the World Health Organisation’s regulatory considerations
The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence...
December 5, 2023
5 min read
Polish government, business associations respond to EU pharmaceutical law reform
Following the EC's announcement of the European Pharmaceutical Strategy[1], the Polish government and...
November 24, 2023
8 min read
Prescribing AI: Contrasting Approaches to AI in Drug Development across the Atlantic
According to a common quip in the U.S. they innovate on the technology front, and the Europeans innovate...
October 19, 2023
9 min read
Circular economy: what impact for healthcare players?
Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment...
September 28, 2023
6 min read