Launch of WHO Pre-qualification Project - Opportunities and Challenges Coexist
Sansheng Pharmaceutical PLC（SSP）and WHO pre-qualification LPA (Local Production & Assistance Unit) expert representatives held the first online video conference on March 23, 2023. Invited by the Ethiopian Ministry of Health, SSP who is the first local pharmaceutical company to pass the GMP audit, has submitted an application for WHO pre-qualification intention in July 2022, and received a confirmation letter from the Ministry of Health in January 2023, which is the symbol of beginning of WHO pre-qualification program. In the video conference, Jiang Zhiwen, the general manager of SSP, and Zeng Dezhi, the deputy general manager, attended the meeting, as well as the representatives from other sector like production, quality, and engineering .
The main contents of the video conference include: introduction of the LPA expert group and the team members of the pre-qualification project of SSP ; introduction of the Sansheng Pharmaceutical profile and the situation of selected products to be pre-qualification ; understanding the scope and content of LPA technical assistance; Discuss the planed pre-qualification products of our company; make plans for the next step.
About WHO pre-qualification
In 2001, an action plan launched by the United Nations, based on the imperfect drug regulatory system in developing countries and weak drug review and regulatory capabilities, WHO issued a list of drugs (EOI list) based on the urgent need for drugs by the public, and those who were invited to enter the list of drugs .The holder who enter the list of drugs can submit product research application document, and the WHO expert group will review the application document, conduct on-site inspections, and evaluate the stability of supplying after entering market and the continuous quality assurance ability of commercial batch products to ensure that the drugs are safe, effective, and quality controllable which pass the review are called Pre-qualification. Subsequently, after the United Nations procurement of suppliers can access to the target market, it will be launched for sale.
The advantage of participating in PQ certification is that, the company can become a procurement supplier of the United Nations or an international foundation, and its products can be listed in many developing countries, which improves the efficiency of listing; then,it can Improve the quality system of the enterprise to reach the international standard, and to serve patients in developing countries better .
Sansheng Pharmaceutical?PLC（SSP）and WHO pre-qualification LPA (Local Production & Assistance Unit) expert representatives held the first online video conference on March 23, 2023，which is the symbol of?beginning of?WHO pre-qualification program.
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