The Chumakov Center of Research and Development of Immunobiological Drugs of the Russian Academy of Sciences (RAS) plans to submit documents to the World Health Organization (WHO) for the prequalification of the coronavirus vaccine, TASS reports references to the center’s CEO, corresponding member of the Russian Academy of Sciences Aidar Ishmukhametov.
“All the necessary documents for registering our vaccine in Russia, as previously reported, have already been sent to the Ministry of Health and now waiting for an official response. We hope to receive registration documents in mid-February. After that, we plan to submit a package of documents to the WHO for undergoing the so-called drug prequalification procedure in order to obtain an assessment of the quality, safety and effectiveness of our drug”, he said.
The pre-qualification program is carried out free of charge by WHO staff and includes the assessment of safety data, effectiveness and quality of drugs in the registration form, as well as an audit of the enterprise for compliance with good manufacturing practice (GMP) rules.
WHO launched the Drug Pre-Qualification Program in 2001 with the Joint United Nations Programme support on HIV/AIDS (UNAIDS), UNICEF and the United Nations Population Fund. Since 2006, the program has included drugs and medical products for reproductive health. At the end of 2012, the WHO list of pre-qualified medicines included more than 316 drugs for major diseases.