Regulatory Oversight and Compliance

The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.

The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.

The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

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.

Nabriva Therapeutics reports that FDA says travel restrictions are preventing the on-site inspection of a European contract manufacturer.

FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.

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 guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.

The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.

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

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

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

According to a report from commercial law firm, Hill Dickinson, there is general support by the public of the United Kingdom that vaccine regulations should be relaxed in light of the current COVID-19 pandemic.

Will efforts to limit all returns on investment drive biopharma companies away from developing much-needed interventions for COVID-19.

The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.

The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.

The agency has added a COVID-19 innovation resource page and an education resources page to its website.