Regulatory/GMP Compliance, Europe

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The agency met to discuss its new temporary and permanent premises in Amsterdam.

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.

The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

The agency and the European Commission published updated guidance to answer questions about Brexit.

During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

The agency has published a continuity plan for its move from the United Kingdom.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.