Increasing the Supply of Quality Assured Medicines
PQM works with manufacturers and collaborates with international health organizations to help increase the supply of quality assured medicines, specifically ones used to treat USAID priority diseases.
Helping Manufacturers Provide Affordable QA Medicines for Tuberculosis (TB)
PQM is assisting the Global Drug Facility (GDF) in its efforts to increase the availability of good quality second-line anti-TB medicines at an affordable price. Currently, there are not enough WHO-prequalified TB medicine manufacturers, resulting in an inadequate supply of QA products to treat patients with multidrug-resistant TB. In order to ensure good quality products, United Nations procurement agencies, Global Fund, and many international and nongovernmental organizations mandate that only medicines prequalified by WHO, or approved by stringent regulatory agencies, are suitable for procurement. Subsequently, an increase in the number of companies applying to WHO for prequalification has stretched WHO's resources.
To assist with the WHO prequalification process, PQM provides technical assistance to interested companies on the preparation of drug dossiers required with the submission of an "Expression of Interest" (EOI). The EOI requires the manufacturer to supply considerable technical information on each product in specific order as presented in the "Information for Applicants" section of the WHO prequalification website. To this end, PQM
- Helps manufacturers prepare their product dossier for submission to the WHO Prequalification Programme
- Facilitates discussions with WHO to remedy incomplete dossiers or to respond to WHO comments
- Guides them onsite in complying with principles and guidelines of WHO Good Manufacturing Practices
How TB Medicine Manufacturers Can Apply for PQM Technical Assistance
Manufacturers that wish to receive technical assistance from PQM may submit their EOI to the WHO prequalification team on the following products:†
- Amikacin, 500 mg/2 ml solution for injection ampule or vial; 1 g powder for injection amp or vial*
- Capreomycin, 1 g powder for injection, vial*
- Cycloserine, 250 mg capsule
- Ethionamide, 250 mg tablet/capsule
- Kanamycin, 500 mg or 1 g powder for injection, vial*
- Levofloxacin, 250 mg tablet/capsule; 500 mg or 750 mg tablet
- Moxifloxacin, 400 mg tablet/capsule
- Ofloxacin, 200 mg or 400 mg tablet/capsule
- Para-Aminosalicylic Acid (PAS), 4 g granules, sachets
- Para-Aminosalicylic Acid (PAS) Sodium, 100 g granules, jar; 4 g or 9.2 g granules, sachets; powder for oral solution, sachets
- Prothionamide, 250 mg tablet/capsule
- Terizidone, 250 mg or 300 mg capsule/tablet
†According to the 10th Invitation (amended), dated February 25, 2011
* With or without diluent water for injection 5 ml vial
Once the GDF has authorized a manufacturer to receive technical assistance, PQM will review the product dossier(s) for completeness, consistency, and credibility and will determine whether the information fulfills the WHO assessment criteria.
Working with PQM does not guarantee WHO prequalification status for any medicine; it offers manufacturers the opportunity to initially present a stronger, higher-quality dossier. Whether assessing preliminary dossiers, conducting GMP inspections, or testing samples for quality, PQM will provide the necessary resources to complement the WHO Prequalification Programme. The stronger the dossier, the more quickly and smoothly it will be processed by WHO.
For further information on the technical assistance PQM can provide, contact Allan Hong at email@example.com or phone +1-301-816-7419; or Edwin Toledo at firstname.lastname@example.org, +1-301-816-8165 or fax +1-301-816-8374.