China has now got more than 300 active pharmaceutical ingredients (API) and 40 preparations on United States market, 25 API and 17 preparations obtained WHO pre-certification.
Wu Zhen, Deputy Director of the State Food and Drug Administration, said that after long-term endeavors China’s generic drug gradually get international approval and have access to international mainstream pharmaceutical market.
Generic drug, which is not a pirate of reference listed drug (RLD) but the replica of it, can perfectly replace RLD as it is exactly the same as RLD on specifications, dosage forms, usage, dosage, quality controllability and efficacy. Promoting generic drug quality has been a pivotal issue since drug examination and approval system reformation was launched in August 2015. As a key link of drug registration reformation, the consistency evaluation of generic drug has become an important supporting work to advance the supply-side reform on healthcare.
The “National ‘12th Five Year Plan’ For State Drug Safety” issued in January 2012 proposed the concept of "Consistency Evaluation of Generic drug" for the first time and requires the generic drug to meet the high requirement of being consistent with RLD on management, process and quality standard in order to comprehensively enhance drug quality and improve overall level of pharmaceutical industry.
Due to the difficulty of obtaining reference preparation resources, the lack of clinical resources, large investment funds and unclear operation path, the implementation of consistency evaluation had been evolving tardily and basically stagnated by the end of 2014.
In 2016, consistency evaluation of generic drug entered policy-driven period. "Opinions on implementing consistency evaluation of generic drug’s quality and efficacy" issued on March 5 defined the evaluation objects, time limit, reference preparation selection principles and evaluation methods selection principles.
On May 25, in accordance with documents No. 8, the State Food and Drug Administration issued “Announcement of Implementing Relevant Matters", which marked the implementation of drug consistency evaluation, had standardized the declaration procedure of generic drug consistency evaluation and made requests on the content of consistency evaluation research.
Carrying out generic drug consistency evaluation will facilitate generic drug being consistent with RLD on quality and efficacy. Clinically replace RLD will not only save medical costs but also help to improve generic drug quality, enhance the overall development level of pharmaceutical industry and ensure public drug safety and efficacy.
Experts said that consistency evaluation for drugs on the market was not mandatory in the past therefore gaps still exist in efficacy on generic drug and RLD; other countries, including the United States and Japan, had also experienced the same process and Japan even spent decades propelling consistency evaluation. For China, generic drug consistency evaluation is as much a remedial work as innovation.
In addition, generic drug that passed the test of consistency evaluation have clinical priority to replace RLD, and will greatly ease people's medication burden, reduce health insurance cost and improve the efficiency of health insurance funds usage and at the same time further promote the internationalization process of China's pharmaceutical industry.
China is a vast pharmaceutical country instead of a pharmaceutical power. In international pharmaceutical market, China is still dominated by API exports, the proportion of preparation exports are fewer whether in varieties or in the sum while the basic reason of this phenomenon lies in its backward preparation level.
China will not only be a vast pharmaceutical country but also become a pharmaceutical power. China’s generic drug quality has been greatly improved through the consistency evaluation and other efforts in recent years. Recently, more than 300 APIs and 40 preparations are selling in the United States which can be seen as the recognition of China’s generic drug quality.
We do have reason to believe that China’s generic drug quality will be elevated significantly by the continuous implementation of a variety of related policies and eventually make its way into international mainstream pharmaceutical market. To promote the quality of generic drug and achieve mutual substitution between generic drug and RLD will be able to propel structural reform in drug production field.
(By our own staff)