Through joint efforts of Tasly Pharmaceutical International, Tasly Sants Pharmaceutical and Tasly Pharmaceutical, the GMP clearance application filed by Tasly Sants was approved in August by TGA or Therapeutic Goods Administration, Australia's regulatory agency for medical drugs and devices. By now Tasly International has successfully penetrated the Australian market after registration with TGA of the first 4 products, Silibinin Capsules, Ginseng RH2 Capsule, Phytoestrogen and Bitter Melon Capsule.

The government of Australia, the first country in the west which has accepted the traditional Chinese medical science by means of legislation, has been carrying out open policies towards the development of this time-tested science and Chinese herbal drugs. The Tasly Healthpac Medical Center of Integrative Medicine was officially established this May as a result of collaboration between Tasly and the Australia-based Healthpac, which marked the first step of Tasly into the Australian market.

It is required in Australia that drugs be registered and approved prior to entry into the local market. Furthermore, before registration, the GMP (Good Manufacturing Practice) system of any overseas manufacturer must be certified by the TGA.

Tasly International and its branch in Australia, after studying the regulatory laws and regulations concerned, found two ways for an overseas manufacturer to obtain TGA certification. The first is through on-site audit. The overseas manufacturer lodges an application for a TGA on-site audit, which will be arranged by the TGA on the basis of its schedule. Generally speaking, it takes 10-12 months for the manufacturer to be granted the GMP certificate and one dosage form costs CNY200,000 or so. The second is through compliance verification. In accordance with international agreements with certain countries, the TGA accepts compliance with the local GMP requirements based on a current GMP certificate. This procedure, which takes two months and one dosage form costs CNY10,000 only, greatly saves costs and time compared with the first one.

Since Tasly Sants and Tasly Pharmaceutical have been GMP-certified by the MHRA and the MEB, Tasly International, together with quality departments of the above two firms, filed GMP clearance applications for the two firms respectively in April and July this year to the TGA. The application of Tasly Sants was finally approved by the TGA after 4-month efforts (Identifier: MI-2014-CL-03212-1) and it is expected that the application of Tasly Pharmaceutical will be approved in October.

In addition, the registration of Silibinin Capsules, Ginseng RH2 Capsule, Phytoestrogen and Bitter Melon Capsule has also been approved by the TGA. It is believed that the above Tasly products will be available on the Australian market later this year to enlarge the international territory of Tasly's Pan-health cause.

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