Regulatory Oversight

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.

Novartis UK has issued a statement specifying its disappointment at the initial decision by NICE to not recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis with active disease.

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 agency will be waiving fees for scientific advice for academia developing orphan drugs.

The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.

EMA has issued a press release on June 18, 2020, in which it endorses two statements from the International Coalition of Medicines Regulatory Authorities (ICMRA) about the importance of the safety and effectiveness of vaccines.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.

An instruction has been issued to all those performing clinical trials using hydroxychloroquine to treat or prevent COVID-19 to stop recruitment of any new patients by the MHRA in the UK.

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

Leo Pharma, medical dermatology specialist, has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.

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.

Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.

FDA and the US Congress support innovation and access to cheaper medicines.

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

The EU’s pharmaceutical strategy has the potential to shake up the policies and regulations of the region’s medicines sector.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

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

Virpax Pharmaceuticals, which specializes in developing pharmaceutical products for pain management using novel drug delivery systems, has announced the successful completion of a pre-investigational new drug (IND) application meeting with the US FDA.

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.

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 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.

A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

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.

The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.