subject: Chinese Pharmaceutical Companies Want To Knock On The Door Of International Procurement - [print this page] "I hope more Chinese pharmaceutical companies to participate in the World Health Organization (WHO) pre-certification, we are for Chinese enterprises to provide relevant technical support." Recently, China Medicine International Exchange Center, WHO, the European Quality of Medicines Authority (EDQM) co-sponsored API The quality of the seminar, several WHO, EDQM's officials all say that.
Involved in international procurement, is one of many in China Pharmaceutical companies Ideal. However, due to the particularity of drugs, WHO and other organizations to enter the drug purchase list of suppliers, you must first pre-certified by WHO (hereinafter referred to as "WHO-PQ"). The company, once a WHO medicines procurement suppliers, will also be the concern of other international funds. In fact, through WHO-PQ, many pharmaceutical companies have become objectives of the efforts, and this process is invariably described as "long and difficult journey."
"In our inspection process, often see the behavior of corporate existence of false data, the data provided by some companies look very pretty, no question, however, the data is usually too good to arouse suspicion." Will on, a WHO official pointedly noted that the Chinese enterprises in WHO-PQ exists a number of significant shortcomings. Yin Hua Jieshao
According to WHO officials in China's preparations to submit certification of enterprises, there are some common problems such as: only available Pharmacopoeia Standards, but did not provide products and Pharmacopoeia of the control; WHO would like to see the original quality standards, change history, effective date, not just the translation ... ... these, and quality-related issues is most important, including the process authentication, device authentication, quality review, change control. The most frequently observed defects include materials management, standard operating procedures, and even the cleanliness of plant, product batch reports, labels, and the plant exist in the cross-contamination. Or, "If the plant is too clean, the cleaning people suspected assault, in the absence of checking whether the time to keep?"
Yin Hua said that the submissions of Chinese enterprises, there are some common problems such as lack of production records, and inadequate description of production process. To note that Pharmaceutical Packaging Materials, standards, methods of identification are needed. Even the preparation of a product description of this, many enterprises can not be completed correctly: If a white tablet, many companies often simply described as "white tablet" and Qualified description should include color, shape, , size, segmentation marks, printing, signs, and quality standards consistent with the characteristics described; such as the description of pharmaceutical packaging, companies with "high-density polyethylene" also failed to describe, should experiment with the stability of the packaging line . Suppose tablet contains separate line, companies must explain the rationality of dividing line, should be divided nature, a uniformity study drugs, FDA standard reference points on the tablet and then asked to experiment.
Yin Hua, said the issue of quality, WHO officials will not miss any details, such as: discussing the increase in purification steps, it would change the nature of drugs? Part of why the lack of drug development or incomplete? May affect the preparation of raw materials production and efficacy of drugs recorded in the where? Compound what each component respectively, and study how the data? Production process is how to choose from? Why there is the phenomenon of over-feeding, with or without good reason? Etc., need to note and do business.
Chinese pharmaceutical companies: a long road, but we strive to
"We have prepared the 5 years, and now the dawn of success is at hand." Elcoteq Beijing Holley, a Chinese limited liability company, delegates said the company's main antimalarial products "Elcoteq complex" tablets the PQ application for registration was received on April 2 WHO-PQ sector to receive, and accept number issued, marking the company formally established with the WHO official technology platforms for dialogue, "Elcoteq complex" formal entry into WHO official review program. "This is a Chinese medicine in the PQ certification established an important milestone. At the same time, WHO-PQ certification number was received, but also to" Elcoteq complex "tablets are eligible to participate in the Global Fund (GF) of the expert review process system, as soon as possible qualification in public procurement. "The representative said the company, if certified by the PQ," Elcoteq complex "on the private market from the current access to public markets in Africa, the product sales will be doubled.
China Medical Quality Management Association International Pharmaceutical Affairs Service Center Dr. Li Wei said that some Chinese companies do not want to do PQ certification, one of language, technical barriers, and second, put too much, too long, companies that the loss outweighs the gain. In fact, international certification despite the current into a larger, but in the long run, it saves the costs of future transformation of GMP. And whether access to WHO-PQ EDQM certification, or certification, means access to a permit to enter the international pharmaceutical market, companies break through technical barriers in developed countries, into the international high-end market will become possible. In addition, PQ certification, like get a high level of "access pass", Export The difficulty will be greatly reduced, but also to promote non-standard markets such as Southeast Asia, South America and other countries and regions of the drugs Sell .
