Regulatory/GMP Compliance

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.

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

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

There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.

EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.

483s and Warning Letters Point to Inadequate Quality Oversight

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

FDA can better monitor quality production of domestic versus foreign firms.

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.

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.

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.

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.

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