Baige contends for the flow-those things that Chinese pharmaceutical companies have passed the WHO PQ certification

Author: There is no doubt that China's pharmaceutical industry, as an important part of the world's pharmaceutical industry, has deeply participated in the cooperation and competition in all aspects of the world's pharmaceutical industry Domestic excellent pharmaceutical enterprises are not only active in the domestic pharmaceutical market, but also actively participate in the competition and expansion of the international pharmaceutical market At first, Chinese pharmaceutical enterprises were in the low-end position of international competition, mainly API enterprises participating in international competition With the increasing strength of Chinese pharmaceutical enterprises, more Chinese pharmaceutical enterprises began to actively expand the international market In these international development projects, in addition to FDA certification and EU certification, there is also a quality system certification for pharmaceutical enterprises, which needs to be given enough attention by Chinese pharmaceutical enterprises, that is, who PQ certification The World Health Organization (who) supplier pre certification is a United Nations action plan launched in 2001 Formerly known as prequalification team: medicines (pqtm), it has been renamed as prequalification of medicines program (who pre qualification, PQ certification), which is used to expand the priority drug access, aims to ensure the quality, efficacy and safety of drugs purchased by international funds (such as gftam, UNITAID) and NGOs, and serve patients in developing countries At the beginning of the establishment of who pre certification program in 2001, the focus was on anti HIV / AIDS drugs, anti malaria drugs and anti tuberculosis drugs In 2006, the scope of pre certification was expanded, and the drugs for promoting reproductive health care were added After 2007, 2008 and 2011, influenza drugs, drugs for children nutrition, acute diarrhea, hepatitis and other easily neglected tropical diseases were successively added The range and varieties of products that are accepted are gradually expanding As of November 2019, the list of preparations pre certified by who includes 554 drugs, which are classified according to treatment as shown in Table 1: Table 1 who supplier pre certification (PQ certification) drug category (FPPS preparation) The scope of who pre certification includes not only preparations, but also APIs and independent quality inspection laboratories In addition, not all drugs can apply for who pre certification This project is only for products included in the list of expression of interest (EOI) published by who (mainly from the WHO essential medicines list, EML) or the recommended list of who disease treatment guidelines), the EOI list directory specifies the specifications and dosage forms of the drugs, and who will accept the certification only if the drugs meet the requirements See Figure 1 for the basic process of PQ certification The pre certification of preparations is divided into full assessment and abbreviated assessment For generic drugs, safety, effectiveness and quality data and information shall be submitted for full review, and field inspection shall be conducted Brief review for generic or innovative drugs that have been approved by SRA with strict standards SRA refers to the drugs approved by the drug regulatory authorities of developed countries recognized by who, who refers to these departments as string regulatory authority (SRA) There are three ways for the pre certification of API: first, full assessment, which is applicable to the API master file (apifm) not previously reviewed by who, The second is the abbreviated assessment, which is applicable to the APIs master file (apifm) that has been previously reviewed by who to support the pre certification of preparations The third is the abbreviated assessment, aiming at the APIs master file (apifm) that has been approved by SRA with strict standards Figure 1 who PQ flow chart (source: WHO website) From September 1, 2013, who drug pre certification began to charge From January 1, 2017, a new charging standard will be implemented, and some products can apply for exemption from the annual fee The details are as follows: Many domestic pharmaceutical enterprises have passed who PQ certification in layout With PQ certification, pharmaceutical enterprises can enter the list of who system international procurement suppliers In addition, many international non-governmental public organizations also recognize the WHO pre certification system, which is also conducive to improving the status of enterprises in the domestic market At present, there are 12 pharmaceutical enterprises that have passed the WHO pre certification and 24 API enterprises (see Table 2 for details) For example, as the leader of who pre certification, the sales revenue of PQ certified varieties in 2018 has exceeded 300 million yuan Table 2 list of domestic enterprises passing who supplier pre certification (PQ certification)