Hundreds of competitions - what Chinese pharmaceutical companies do by whose WHO PQ certification

There is no doubt that China's pharmaceutical industry, as a pivotal part of the world pharmaceutical industry, has been deeply involved in all aspects of the world pharmaceutical industry cooperation and competitionDomestic outstanding pharmaceutical enterprises not only actively in the domestic pharmaceutical market, but also actively participate in the international pharmaceutical market competition and expansionInitially, Chinese pharmaceutical companies are in the low end of international competition, mainly RAW materials enterprises to participate in international competitionAs China's pharmaceutical companies strengthen their strength, more Pharmaceutical companies in China began to actively expand the international marketIn these international expansion projects, in addition to the United States FDA certification, EU certification, there is a pharmaceutical enterprise quality system certification, need Chinese pharmaceutical companies to give enough attention, that is, WHO PQ certificationWorld Health Organization (WHO) supplier pre-certification, a United Nations action plan launched in 2001, formerly known as Prequalification Team: Medicines (PQTm), now renamed Prequalify of Medicines Programme (PQ Certification) for the purpose of expanding access to selected priority drugs, with the aim of ensuring the quality, efficacy and safety of medicines procured by international funds such as GFTAM, the United Nations Assistance International Drug Purchase Facility, and NON-governmental organizationsWHO pre-certification project was established in 2001 with a focus on anti-HIV/AIDS drugs, antimalarial drugs, anti-tb drugs, the scope of pre-certification in 2006 expanded to promote reproductive health drugs, followed by the increase in 2007, 2008 and 2011 influenza drugs, for child nutrition, acute diarrhoea, hepatitis, other easily overlooked tropical diseases and similar varieties of products, the scope and acceptance of the product seriesAs of November 2019, the list of pre-certified preparations through the WHO includes 554 drugs, according to the treatment classification as shown in Table 1:Table 1 WHO Supplier Pre-Certified (PQ Certified) Drug Types (FPPs Preparations)WHO Pre-Certification Range In addition to the preparations, including API and independent quality laboratory, and not all drugs can be applied forWHO pre-certification, the project is only for whopublished the product evaluation letter of intent (Express of Interest, EOI) list of products (which mainly comes from the WHO Essential Medicines List (Essential Medicines List, EML) or the RECOMMENDed list of WHO disease treatment guidelines), the EOI list details the specifications and dosage forms of the drug, only the required drugs, WHO will accept certificationthe basic process of WHO PQ certification
The basic process for PQ certification is detailed in Figure 1Pre-certification ofpreparations is divided into full assessment and abbreviated assessmentA full review of generics requires the submission of safety, effectiveness and quality data and information, as well as on-site inspectionsA brief review of generic or innovative drugs that have been approved by the SRA to strict standards SRA refers to drugs approved by the WHO's approved drug regulatory authorities in developed countries, which are referred to as The Regulatory Authority (SRA) Pre-certification of API can be achieved in three ways: first, full Assessment, for APIFM, which has not previously been reviewed by WHO, abbreviated assessment, for pre-certified APIFM (APIFM) for preparations previously reviewed by WHO, and abbreated for strictly approved APIFM Figure 1 WHO PQ Flowchart (Source: WHO official website) From September 1, 2013, WHO drug pre-certification began charging From 1 January 2017, new fees will be introduced and some products may be exempted from the annual fee specific as follows: domestic pharmaceutical enterprises in the layout of WHO PQ certification, through WHO PQ certification, pharmaceutical enterprises can enter the WHO system of international procurement suppliers directory, in addition, many international non-governmental non-public welfare organizations also recognized the WHO pre-certification system, which is also conducive to improving the status of enterprises in the domestic market, currently through the WHO pre-certified preparation enterprises have 12, API enterprises have 24 (see table 2) Such as Guilin South Medicine as the LEADER of WHO pre-certification, 2018 PQ certified varieties of sales revenue has exceeded 300 million yuan Table 2 by WHO supplier pre-certification (PQ certification) of the list of domestic enterprises
from the above list can be seen, after these years of efforts and development, a number of Pharmaceutical enterprises in China have passed PQ certification, and actively expand the international pharmaceutical market Among them, Guangxi Guilin South medicine as a forerunner, has achieved remarkable results But compared with Indian companies, we will find that we still have less attention, fewer varieties, less export performance of enterprises, so we need to continue to work.