There are a significant number of legal and practical considerations regarding product recall requirements in Germany.
In a Q&A with Lexology, our lawyers discuss notification requirements, and much more, in-depth.
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On September 9, the US House of Representatives passed H.R. 8333, known as the BIOSECURE Act, targeting WuXi AppTec, BGI, MGI, Complete Genomics, WuXi Biologics and Chinese biotechnology companies more broadly.
Measures & Context
If signed into law, the BIOSECURE Act would prohibit entities that receive US federal funding from doing business with foreign biotechnology companies affiliated with the People’s Liberation Army, including the five Chinese biotechnology companies explicitly named in the bill. The bill also seeks to prevent the transfer of US persons’ genetic information to foreign adversaries.
The bill addresses concerns that foreign biotechnology companies, particularly Chinese companies, could use genetic data for surveillance or espionage.
The bill’s measures are part of a broader set of restrictive measures against China following the passage of the Secure and Trusted Communications Networks Act. This law prohibits federal agencies from purchasing telecommunications equipment from certain foreign companies, including those from China, due to security concerns, and prevents them from contracting with companies that use such prohibited equipment.
In a judgment dated March 12, 2024, the Court of Justice of the European Union (the “Court of Justice“) was asked to clarify the scope of the principles that must be respected in the procedure conducted by the European Medicines Agency (EMA) for the evaluation of medicinal products.
Background
The appeal to the Court of Justice follows an application for a conditional marketing authorization submitted to the EMA on June 26, 2018, for Hopveus, a drug for the treatment of alcohol dependence.
On October 17, 2019, the Committee for Medicinal Products for Human Use (CHMP), which is part of the EMA, issued a negative opinion on this application.
In response, the applicant submitted a request for re-examination, for which the CHMP convened an ad hoc expert group, which included an expert who was also an investigator for another medicine also intended for the treatment of alcohol dependence (AD 04). Following a new unfavorable opinion dated April 30, 2020, the European Commission rejected the conditional marketing authorization.
To challenge this rejection, the applicant brought an action against the Commission and the EMA before the General Court of the European Union (the “General Court“), seeking annulment of the [...]
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