Successful Launching of MEBO in Australia

2013年-03月-14日来源：MEBO

Successful Launching of MEBO in Australia

After nearly two years of thoughtful preparation and planning and with joint efforts of Registration Department, Marketing Department, Technical Department of International Market Group and MEBO Medical Factory (Shantou), MEBO Moist Burns Ointment is registered in Australia on March 1^st of 2013 as a registered medicine for burns and ulcers through repeated communication with local officials, strict on-site auditing and preparation, supplementation and modification of application materials. This is MEBO’s first time to access into major western developed countries and a new milestone of MEBO International Group.

This time, the successful registration of MEBO Moist Burns Ointment in Australia forged several examples. First, the indication registered includes burns, frostbites, incisions and contusions and many other indications related to epidermis damage. It is the most comprehensive indications ever with regard to product registration in MEBO International. At the same time, we are proud to find that obvious introduction of promoting regeneration and restoration of skin wounds by stem cells was made in MEBO Moist Burns Ointment product description, signaling the approval of the theory of human body regeneration and restoration science by western countries and laying solid technical foundations for the market development in Australia. Now, the Marketing Department is closely coordinating with agents in Australia in order to promote the market development and realize market operation.

As we all know that Australia, being one of the developed countries in the west, is a very strict market in terms of pharmaceutical products administration and access management and the approval procedure for all listed pharmaceutical products. And, before approval, TGA of Australia will audit the manufacturing factories according to requirements of cGMP. Those who got approval can start registration process. The supervision of TGA is nearly as strict as FDA of the United States and EAMA of European Union and is at the same level with JFDA of Japan. For pharmaceutical products manufacturers outside Australia, lots of technical bacteria remain with regard to listing products. Factories that are comparatively less powerful will face huge obstacles.

Currently, few Chinese pharmaceutical companies operate in Australia. On the one hand, differences in such industry in both countries still remain. Chinese pharmaceutical companies take up very small proportion in markets of developed countries. The existing exports are mainly chemical bulk drugs. The pharmaceutical preparations are still rare. On the other hand, domestic natural medicines/Chinese patent drugs have long been rejected in non-Chinese regions overseas due to differences between traditional Chinese medical concept and western modern medical methods and theoretical system. So, they are hard to access into western developed countries. This is definitely true.

At present, related product information of MEBO Moist Burns Ointment has been recorded into official ARTG database, the product registration number has been generated and the drug certificate will be issued. After successful listing into market, the popularity and reputation of MEBO products have been greatly promoted and great breakthrough has been realized in international market development. What is more important is that Australia TGA is one of members of PIC/S. Other members include 45 drug administration systems of developed countries, e.g. United States, Britain, France, Germany, Italy and Denmark. All members of PIC/S will recognize certificates of one another. However, being the major manufacturer of MEBO burns ointment, MEBO (Shantou) has acquired approval from TGA GMP before Christmas of 2010. In addition, the listing of products, together with the above achievements, mean that burns ointment will not be audited on site in principle by drug administration departments of such countries when they are reporting to be listed in these high-end markets. Actually, this simplifies approval process and reduces listing costs, representing a good start to access into such markets.
We believe that MEBO will enjoy a more prosperous and wonderful future.

March 13^th of 2013
From MEBO International