HSA’s role in regulation of BMS in Singapore
When joining the Biomedical Sciences sector, it is essential to understand the industry itself. BMS is a dynamic and fast paced industry which is diverse in its political systems, culture and economic development. A strong and fast growing industry that has the capability of driving a country’s economy cannot be left unregulated. Regulations plays an important role in the any industry and the BMS sector is not excluded.
The Health Sciences Authority (HSA) is the regulatory arm of Singapore in protecting and advancing national health and safety. Their role fundamentally is to safeguard the welfare of public health through strict regulations of medical devices, medicines and health products.
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From the headline above, we have seen the active role that HSA has played in the recent years, warning the public and actively collaborating with other countries to improve regulatory standards. The role played by HSA in this sector is similar to that played by U.S. Food and Drug Adminstration (FDA). In fact, HSA are involved in collboration with several Healthcare regulatory bodies including the FDA and UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) under the Memorandum of Understanding (MOU).
Industrial players in the BMS sector are subject to the regulations placed by HSA.
Any drugs and healthcare devices need to pass the stringent requirements placed by HSA. These includes issues on Good Manufacturing Process (GMP) which deals with the manufacturing process and the safe safe of the final products. These are done through closely monitoring the consumer market and proper networking with other regulatory bodies. Being able to predict potential issues and hazards through information sharing, it allows the regulatory bodies and make swift and effective decisions. From past incidents, taking the famous Slim 10 scandal in year 2002, it has been validated that compliance to the regulatory framework administered by HSA is important and essential.
Proper regulatory frameworks provides companies the capability to compete effectively and efficiently on the global scale. Stringent requirements are a core component to gain the confidence of the public and consumers. With strong consumer confidence in the regulations, industry players will have the luxury of having the publics trust with products that have passed the tests of the HSA.
Image: Flickr/magic pills
While regulating the availability and safety of drugs is desirable, how does HSA balance this against over-regulation which may block access to key drugs, and sometimes, life-saving drugs?
In view of the growing medical technology manufacturing industry regionally, how is HSA regulating the medical devices available in the market?
When it comes to striking a balance between over regulation and under regulation, HSA embarks on means of smart regulation. HSA main focus of drug reviews are on drugs that have little or no regulation history. In addition, drugs that have gone through rigorous reviews by other regulatory bodies like the US FDA or the European Medicine Agency will have its own review by HSA accelerated.
To strengthen its regulatory capabilities, HSA have also come up with innovations that makes use of its extensive network to facilitate interactions with medical devices establishments and health care bodies. An example of this is the MEDICS@HSA system and the electronic medical record systems that HSA shares with the National Healthcare Group. This allows HSA to strengthen its surveillance capability and act swiftly on any issues.
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