First Mainland Manufactured CM Begins Drug Registration Process in EU
In 2004, the European Union (EU) published DIRECTIVE 2004/24/EC amending the Community code as regards traditional herbal medicinal products. As required by the new Directive, herbal medicines need to be registered as part of the Traditional Herbal Medicines Registration Scheme. A seven-year transitional period has been granted to products legally on sales on the UK market at 30 April 2004. They do not need to be registered until 30 April 2011. Under this simplified registration scheme, products are still required to meet specific standards of safety and quality and be accompanied by agreed indications, based on traditional usage, and systematic patient information allowing the safe use of the product. The Directive is seen as a green light for manufactured Chinese medicine (CM) to enter the European market as medicinal drugs. At the same time, it also presents the regulatory requirements on CM quality standards and control mechanism which must be met for exporting to the EU.
In order to set foot in the U.S. and EU market, mainland pharmaceutical companies are building up quality certification and production systems which live up to the international standards. Guangzhou QiXing Pharmaceutical Co. Ltd, for example, began the drug registration process and GMP certification for the European Union recently. It was the first mainland Chinese pharmaceutical company seeking to take a drug to Europe and a regulatory application on a product had been submitted to the UK authority. The project received support from Guangzhou City to strengthen its R&D base in meeting regulatory requirements for the European market.
Overseas registration for CM will not only act as a gateway to international markets, it also helps boost product sales in the local market. The Cardiotonic Pill of Tasly Group, the first FDA-approved drug from PRC, had gained substantial market share since it was launched in the US. This “registration plus end-user-promotion” mode is being widely adopted by other mainland pharmaceutical companies. They may further seek drug registration in European countries, Japan and other countries. CM overseas registration may be a complicated and costly process. However, with the favourable policies and supports from the government, it is a sensible step to take by mainland pharmaceutical companies.
Mainland manufactured CM import/export amounted to US$152 million for the first six months of 2009, accounting for 16.67% of total CM import/export. However, the increasingly stringent requirements imposed by other CM importing countries presents a major challenge to CM manufacturers. To take CM brands to the international market, innovation, R&D and registration will be the essential processes to go through.
Sources:
Medicine Economic News www.yyjjb.com.cn
Guangzhou Qixing Pharmaceuticals Co. Limited www.qixing.com.cn
European Herbal & Traditional Medicine Practitioners Association www.ehpa.eu |
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