Regulatory/GMP Compliance, Europe

Several Medicines Recommended by EMA’s CHMP in October

October 18, 2024

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

EMA Denies Authorization of Duchenne Muscular Dystrophy Treatment, Again

October 18, 2024

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

EMA and HMA Publish Network Strategy for Public Consultation

October 11, 2024

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

CPHI Milan 2024: Evolution of Aseptic Processing Equipment for Regulatory Compliance

October 09, 2024

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan.

Responding to the Increased Use of Generative AI

October 01, 2024

Regulators, EMA and HMA, have published principles and recommendations on the use of LLMs, which are being increasingly used for daily tasks.

EMA Suspends Sickle Cell Disease Medicine

September 27, 2024

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

EMA Gives Approval to Several Cancer Treatments

September 23, 2024

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

European Artificial Intelligence Act Comes into Force

September 01, 2024

What impact will the AI Act have on pharma and digital medicine?

Germany Amends and Approves the New Medical Research Act

August 05, 2024

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

Frontrunners in Automated Cell and Gene Therapy Manufacturing

August 04, 2024

Innovative solutions are making personalized cell and gene therapies accessible to all.