January 2022

· 7 min read

African Medicines Agency, Drug Shortages & More - January 2022 Pharma News

The January 2022 pharmaceutical news update looks at the creation of the African Medicines Agency, nitrosamine impurities, European drug shortage issues and more.
African Medicines Agency - January 2022 Pharma News } NSF International

Welcome to the January 2022 pharmaceutical news update. The first edition of the new year looks at the creation of a new African Medicines Agency, nitrosamine impurities, the establishment of HERA and EU efforts to monitor future drug supply shortages.

EU Moves To Monitor Medicine Supply and Prevent Shortages

A proposed new regulation will give the European Medicines Agency (EMA) a tool for monitoring medicine supply and preventing shortages in the event of a significant public health crisis, such as a future pandemic. The European Shortages Monitoring Platform will gather information on drug shortages, supply and demand. This electronic platform will need to determine the volume of stock available at any given moment and detect, predict and prevent drug shortages. The EMA would also maintain a public web page with information on shortages of critical medicines and devices.

On October 28, the European Parliament and the Council of the EU reached a provisional agreement on the draft regulation reinforcing the EMA’s mandate to include monitoring medicine supply. This regulation is part of the European Health Union package, which contains a strengthened mandate for the European Centre for Disease Prevention and Control (ECDC) and a draft law on cross-border health threats. The text of the new regulation is yet to be finalized and adopted; the expectation is that this will happen in Q1 2022. It is likely to be another three years before the EMA monitoring platform is in place.

EU Compilation of Union Procedures on Inspections and Exchange of Information, Revision 18

Revision 18 of the Compilation of Union Procedures on Inspections and Exchange of Information has been published. The following sections are new and worth taking note of:

  • Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making
  • Procedure for managing rapid alerts arising from quality defects risk assessment
  • Outline of a Procedure for Coordinating the Verification of the GMP Status of Manufacturers in Third Countries
  • The Issue and Update of GMP Certificates
  • Procedure for dealing with serious GMP non-compliance requiring coordinated measures to protect public or animal health
  • Procedure for dealing with serious GMP non-compliance information originating from third-country authorities or international organizations
  • Procedure for compliance management
  • Interpretation of the Union format for manufacturer/importer authorization
  • Interpretation of the Union format for a GMP certificate
  • Interpretation of the Union format for wholesale distribution authorization (medicinal products for human use)
  • Union format for a GMP certificate
  • Statement of non-compliance with GMP

Each of the documents listed above was adopted on September 21, 2021. Many of these items came into force in late 2021, while others will have up to nine months to do so.

African Medicines Agency

The treaty establishing a new African Medicines Agency (AMA) came into force on November 5, 2021, when Cameroon became the 15th member state of the African Union to deposit its instrument of ratification of the treaty. The other 14 participants are Algeria, Benin, Burkina Faso, Gabon, Ghana, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leona and Zimbabwe.

The AMA will not be a standalone medicines regulator but will play a coordinating role similar to that of the EMA in the EU, helping to promote regulatory harmonization and collaboration at national and regional levels across the continent. AMA responsibilities will include coordinating GMP inspections, safety-monitoring activities and joint reviews of clinical trial applications.

The location of the new AMA headquarters is unknown at the time of writing. The African Union Commission has asked member states to submit proposals to host the AMA headquarters.

FDA Updates on Possible Mitigation Strategies to Reduce the Risk of Nitrosamine Drug Substance-Related Impurities in Drug Products

The U.S. FDA recently received additional reports of certain types of nitrosamine impurities that formed in several drug products. Nitrosamine drug substance-related impurities (NDSRIs) are nitrosamines that share structural similarities to the API. NDSRIs can be generated during manufacturing or during the shelf-life storage period of the drug product. In some cases, the root cause of NDSRI formation can be attributed to nitrite impurities present in excipients at parts-per-million amounts. Nitrite impurities have been observed in a range of commonly used excipients (as well as water) and may lead to the formation of NDSRIs in certain drug products.

The FDA expects manufacturers to ascertain the presence of nitrosamines, including NDSRIs, using the three-step mitigation strategy described in the agency’s guidance. Manufacturers should now be engaged in the confirmatory testing and reporting stages of their mitigation activities (steps two and three). If NDSRIs are detected in the drug product at objectionable levels, the FDA encourages applicants to develop control strategies and/or design approaches to reduce NDSRIs to acceptable levels.

NSF International has looked at the nitrosamine impurities issue in depth with a series of articles and webinars on this website.

Thurloch O’Críodain presented a webinar in 2020 entitled “Nitrosamines in Medicinal Products — Assessing the Risks.” You can watch it below.

NSF Resources

NSF works with companies around the world on the full life cycle of issues within the pharmaceutical sector. Our clinical research organization, Amarex, based in Maryland in the U.S., conducts clinical studies and clinical trials across all phases of clinical product development. You can find out more about Amarex here.

NSF Pharmaceutical Training provides in-house and public training on a wide range of topics, delivered by world-class instructors. Find out more about NSF Pharmaceutical Training.

NSF Pharma and Biotech consulting works on projects such as GMP auditing, compliance, remediation and quality system development to support the development, manufacture and delivery of safe and effective medicinal products. Find out more about NSF Pharma and Biotech consulting services.

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