Regulatory/GMP Compliance, Europe

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

Emer Cooke, currently the director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, has been nominated by EMA’s management board to be the new executive director of EMA.

The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.

Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.

The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.

The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic.

The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.