Webinar: Streamlining drug approvals for anti-TB and other medicines 

Last month, the U.S. Food and Drug Administration (FDA) in collaboration with PQM+ hosted a free, virtual conference, Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines. More than 3,400 participants from 125 countries attended. Keynote speakers included Janet Woodcock, Principal Deputy Commissioner, FDA, and Dr. Atul Gawande, Assistant Administrator for Global Health, U.S. Agency for International Development (USAID).

The conference was designed to help national regulators in low- and middle-income countries better understand FDA’s drug approval pathways and the agency’s review of drug applications for brand and generic drugs, including medicines to treat tuberculosis. In addition, viewers learned about the role FDA plays in international regulatory harmonization and how PQM+ can help countries strengthen their medical product regulatory systems. Watch sessions from the three-day webinar.

Implementing a risk-based approach to post-marketing surveillance enables countries to use a streamlined strategy for sampling and testing medical products, saving both time and resources. PQM+ collaborated with the Food and Drug Authority in Ghana to conduct its first risk-based post-marketing surveillance (RB-PMS) exercise, which covered three antimalarials and two maternal health medicines. The results helped to inform regulatory actions. Read more.

Developing capacity to conduct GMP inspections in Nigeria

In a recent, hands-on training in Nigeria with the Centre for Drug Discovery Development and Production, PQM+ mentored participants to improve their capacity to conduct inspections of pharmaceutical manufacturers and ensure they comply with good manufacturing practices (GMP). One of the sessions, which focused on a mock inspection of a local pharmaceutical manufacturer, included a review of the findings with facility personnel. Learn more about GMP and enroll in our free, online course.

Building manufacturing sustainability in Nepal

In Nepal, we’re collaborating with the country’s only public pharmaceutical company, Nepal Aushadhi Limited (NAL), to achieve compliance with GMP and build sustainability. Key activities include upgrading a water treatment system, redesigning a microbiology laboratory, and improving an air handling unit to meet regulatory standards. These enhancements will help Nepal produce more quality-assured medical products locally.

Strengthening quality assurance in Bangladesh

This summer, PQM+ hosted a high-level visit with the leaders of the Bangladesh Directorate General for Drug Administration (DGDA), Director General Mohammad Yousuf and Director Md Salahuddin, to discuss our collaboration to strengthen medical products quality assurance systems for millions of people in Bangladesh. 

DGDA oversees medical product quality and implements pharmaceutical policy, registers medicines, approves licenses, and inspects pharmaceutical facilities. One of DGDA’s key functions is post-marketing surveillance of medical products, like vaccines and medical devices. PQM+ is helping DGDA towards achieving WHO maturity level 3 for vaccine regulation.

Supporting tech transfer and diagnostic labs in Pakistan

When an antiviral medicine, remdesivir, emerged as a treatment option for COVID-19, PQM+ facilitated the technology transfer to one of Pakistan’s largest pharmaceutical manufacturing companies. By building technical capabilities to produce the drug locally according to international best practices, we helped the manufacturer develop a plan to export the product to more than 15 countries.

In addition, we strengthened diagnostic laboratories in two public hospitals in Pakistan, including the Institute of Public Health in Lahore, which recently achieved ISO 15189 certification. This marks an important milestone in improving Pakistan's health system. 

As part of the U.S. government’s initiative for global vaccine access, also known as Global VAX, USAID obligated $7.1 million in additional funding to the PQM+ program to strengthen regulatory and/or manufacturing capacity in six African countries - Ghana, Kenya, Nigeria, Rwanda, Senegal, and South Africa - to expand access to COVID-19 vaccines. The program will work with national stakeholders, such as regulatory authorities and local USAID missions, to develop tailored assistance to achieve country-specific goals. Learn more.