May 1, 2009: The Thailand government has undertaken a number of policy initiatives as well as legislative and administrative measures with a view to provide support and create an environment conducive for the growth of the country’s life sciences sector. The Thailand National Biotechnology Policy Framework 2004-2009 was initiated in late 2003 to act as a catalyst to promote biotechnology investment and create new bio companies. The medical devices industry in Thailand, when compared to others is not growing as much. Last year, the Thai government has implemented a new Medical Device Act, replacing its 20-year-old Act. This new Act details regulations and requirements for product registration, advertisements, and punishments for non-compliance.
Despite, the current political turmoil in the country and the global economic downturn, which are becoming barriers for the growth of the industry, the life science associations in Thailand are looking forward to a bright future of the sector and making concerted efforts to reach there. In this issue BioSpetcrum features the Thai Medical Device Technology Industry Association (THAIMED) and Pharmaceutical Research and Manufacturers Association (PreMA).
Thai Medical Device Technology Industry Association
FactFile
The Medical Products Suppliers’ Association (MPSA), which was formed two decades ago as a common forum for the medical devices suppliers’ of Thailand, was renamed as Thai Medical Device Technology Industry Association (THAIMED) in 2005. This move was to enable the associated organizations and industries to become members. THAIMED is now recognized by many local government agencies and by the medical profession, as the representative body of the medical device industry in Thailand. The association provides its members a common platform to act upon the matters of mutual interest and importance.
According to Mr Noppadol Taweetungworapan, President of THAIMED, considering the huge potential of this industry the government is planning to make big investments to expedite the growth of the industry. The government has announced a $1400 billion (THB 50000 billion) budget for the year 2010, and a considerable amount is likely to be allocated for the medical device sector.
The association is the official representative of the government’s medical device committee under the new Medical Device Act. According to Mr Noppadol, lot of changes are expected with the new Act, similar to that of Europe and the US, in vigilance of clinical use, manufacturing and setting the quality standards.
Objectives
The major objectives of THAIMED are: to improve communications and create a stable business relationship between member companies engaged in the distribution of medical products to government and private hospitals throughout Thailand; to promote high professional standards within the industry and to ensure the availability of high quality and dependable products and repair services to customers in support of the health of the Thai people; and to offer the government and the private sector, professional counsel and advice on issues affecting medical products and their supply.
Achievements
The association has established excellent contacts with the Medical Device Division of the Thai Food and Drug Administration (TFDA), thereby providing assistance to members when Free Sales Certificates become a mandatory requirement for the importation of medical devices. Today, this relationship has further strengthened and deepened to the extent that members of the association’s Board now sit on various TFDA sub-committees to assist with and give advice on, matters relating to the medical device industry. The association also keeps in contact with The European Medical Technology Industry Association and the equivalent US organization, the Advanced Medical Technology Association (AdvaMed), ensuring that it keeps abreast of changes in international policy and legislation thereby enabling early discussions with the TFDA on all new developments.
The association monitors all developments concerning GMP, ISO and CE marking and relays all relevant information on these to its members and to the TFDA. The association’s Regulatory Affairs Sub-Committee, consisting of Registration Managers from several member companies, ensures a close focus is kept on regulatory affairs and provides early opportunities to discuss these with the TFDA.
Pharmaceutical Research and Manufacturers Association
In July 1970 the Association was setup under the name Pharmaceutical Products Association (PPA). Later in 2004, the name of the PPA was changed to the Pharmaceutical Research and Manufacturers Association (PreMA) to better reflect the organization’s role. PReMA, founded as a non-profit organization, is made up of 38 research-based pharmaceutical companies in Thailand. It plays a key role as a medium between the member companies and all other stakeholders in the healthcare system. The association promotes ethical and internationally accepted practices, provides services to members and represents their interests when collaborating with the government.
Activities
PReMA regularly arranges seminars and training courses together with the government, academic groups and other private sector organizations. PReMA has co-hosted the second World Federation of Proprietary Medicine Manufacturers’ Asia Pacific Regional Meeting and the Third IFPMA Asian Regulatory Conference. PReMA also provides technical development courses for members, physicians and officials from the Thai Food and Drug Administration. PReMA also cooperates with the Medical Services Department to conduct training courses to introduce GCP to physicians working within the department.
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