Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
12:13 2011-04-30
The European Commission issued a press release on the 29th, announcing that the EU's *Traditional Herbal Medicinal Products Directive* will be fully implemented starting May 1. From that date onward, unregistered traditional Chinese medicines (TCM) will no longer be allowed to be sold or used as medicinal products in the EU market. According to EU officials, as of now, not a single TCM product has been registered.
In the press release, the European Commission stated that the *Traditional Herbal Medicinal Products Directive* aims to provide a simplified registration procedure for traditional herbal medicines, including Chinese herbal medicines, distinct from the registration methods for chemical drugs. Its full implementation will help ensure the safety of European patients' medication.
The EU's *Traditional Herbal Medicinal Products Directive*, which came into effect on April 30, 2004, requires traditional herbal medicines, including TCM, to apply for registration with the competent authorities of member states. Only after approval can they continue to be sold and used as medicines in the EU market.
To allow the herbal medicine industry time to complete registrations, the directive provided a seven-year transition period. This means that during the transition period ending on April 30, 2011, traditional herbal medicines could still be sold and used, but they had to complete registration as soon as possible. Otherwise, starting May 1, they would no longer have access to the EU medicinal market.
Frédéric Vincent, spokesperson for the European Commission's health and medical affairs, informed reporters that, according to incomplete statistics, around 350 herbal medicines successfully registered during the transition period, but not a single TCM product was among them.
It is understood that excessively high registration "thresholds" are the main reason TCM struggles to gain approval. Although the directive simplifies the registration process compared to Western medicines, many TCM companies are deterred by the difficulty of providing proof of 15 years of medicinal use in the EU, along with registration costs amounting to millions of yuan.
Vincent clarified that the EU directive is not intended to impose a blanket ban on TCM, nor will it lead to such an outcome. The EU has taken note of concerns raised by relevant Chinese parties.
He explained that the directive targets herbal medicines. Even after May 1, some TCM products can still be sold and used as food or health supplements, as they were in the past, as long as they do not claim to treat or prevent specific diseases—no registration is required in such cases. The specific classification as either medicine or food will depend on individual member states.
(Source: Xinhua News)
Source: http://www. chinesemedicaldaily. com/ news- 2395/
Traditional Chinese Medicine Banned in EU Starting May 1
The European Commission issued a press release on the 29th, announcing that the EU's *Traditional Herbal Medicinal Products Directive* will be fully implemented starting May 1. From that date onward, unregistered traditional Chinese medicines (TCM) will no longer be allowed to be sold or used as medicinal products in the EU market. According to EU officials, as of now, not a single TCM product has been registered.
In the press release, the European Commission stated that the *Traditional Herbal Medicinal Products Directive* aims to provide a simplified registration procedure for traditional herbal medicines, including Chinese herbal medicines, distinct from the registration methods for chemical drugs. Its full implementation will help ensure the safety of European patients' medication.
The EU's *Traditional Herbal Medicinal Products Directive*, which came into effect on April 30, 2004, requires traditional herbal medicines, including TCM, to apply for registration with the competent authorities of member states. Only after approval can they continue to be sold and used as medicines in the EU market.
To allow the herbal medicine industry time to complete registrations, the directive provided a seven-year transition period. This means that during the transition period ending on April 30, 2011, traditional herbal medicines could still be sold and used, but they had to complete registration as soon as possible. Otherwise, starting May 1, they would no longer have access to the EU medicinal market.
Frédéric Vincent, spokesperson for the European Commission's health and medical affairs, informed reporters that, according to incomplete statistics, around 350 herbal medicines successfully registered during the transition period, but not a single TCM product was among them.
It is understood that excessively high registration "thresholds" are the main reason TCM struggles to gain approval. Although the directive simplifies the registration process compared to Western medicines, many TCM companies are deterred by the difficulty of providing proof of 15 years of medicinal use in the EU, along with registration costs amounting to millions of yuan.
Vincent clarified that the EU directive is not intended to impose a blanket ban on TCM, nor will it lead to such an outcome. The EU has taken note of concerns raised by relevant Chinese parties.
He explained that the directive targets herbal medicines. Even after May 1, some TCM products can still be sold and used as food or health supplements, as they were in the past, as long as they do not claim to treat or prevent specific diseases—no registration is required in such cases. The specific classification as either medicine or food will depend on individual member states.
(Source: Xinhua News)
Source: http://www. chinesemedicaldaily. com/ news- 2395/