Malaysia - SIRO Clinpharma to Better Serve Regional Clients05 May 2011 • by Natalie Aster
BMI View: SIRO Clinpharma’s new operations in Malaysia will allow it to better serve new and existing clients in Asia. The Malaysian government has been actively supporting pharmaceutical research by speeding up medical approvals and providing transparent clinical trials registrations. However, more has to be done in order to boost Malaysia's competiveness against technological hubs like Singapore and Hong Kong.
Global clinical research organisation (CRO), SIRO Clinpharma has launched operations in Malaysia as part of its strategy to extend its presence in Asia. This move will allow the company to gain additional geography to conduct clinical trials for new and existing clients. Previously in 2010, the company co-operated with CROs in South Korea and Taiwan for similar reasons.
Outsourcing of pharmaceutical services has become a trend, as major drugmakers have started to embrace the fully integrated pharma network (FITnet) model (a term coined by Eli Lilly & Co). This is in contrast to fully integrated pharma company (FIPco) model in which pharmaceutical companies hold expertise in all areas of pharmaceutical development. According to Association Of Clinical Research Organisations (ACRO), industry revenue was projected to be US$20bn in 2010.
Besides reducing costs, outsourcing allows pharmaceutical companies to gain access to good regulatory and information management that CROs would have established. In addition, drug companies are able to focus more on other issues such as drug discovery. There is also an added advantage outsourcing to local CROs which is their deeper understanding of the country, including its language, cultures and regulatory policies. This know-how will speed up clinical trials implementation.
SIRO Clinpharma's interest in Malaysia lies in the fact that the country boasts a robust regulatory framework, strong government commitment towards clinical research and modern medical facilities, according to its president of Asia business. According to the Industry Risk component of BMI's Pharmaceutical Risk/Reward Ratings, Malaysia ranks fourth in the region, scoring 70.2, which is well above the regional average of 55.8. The ratings take into consideration various factors of which approval processes, intellectual property (IP) laws are prudent to clinical trials.
In its effort to support clinical trials, the government put forth the National Medical Research Register (NMRR) in 2010, a web-based registration process that requires clinical trials to be registered and relevant information to be made publicly accessible, which is in line with international practices. The country's overall pharmaceutical research environment is further boosted by the proposal to shorten medicine approvals from six to two months. These changes will increase drugmaker revenue in the South East Asian country and consequently facilitate foreign direct investment into manufacturing plants and research and development (R&D) facilities.
However, Malaysia still lags behind technological hubs like Singapore and Hong Kong or with places with a huge population such as China and India. From BMI's technological infrastructure ratings, both Singapore and Hong Kong scored 81.0 and 72.2 respectively while Malaysia is much further down the list scoring 45.9. According to ClinicalTrials.gov, Malaysia has carried out a total of 372 trials since 2000. While Singapore executed 801 studies within the same time frame.
Number of Clinical Trials in Malaysia, Singapore and Hong Kong
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