Regulatory/GMP Compliance, Europe

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.

Two of the medicines recommended for approval are orphan drugs.

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.

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

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

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.

Europe updates the guideline on excipients information in labeling and packaging.

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

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

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 meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

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 is asking public consultation on the concept paper.

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.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The directorate highlights its 2016 achievements.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.

The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.

The agency published an action plan to nurture innovation and drug development by SMEs.