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Overview Despite the country’s small size, Singapore boasts a highly-developed economy and serves as an Asian hub for numerous medical companies. In total, Singapore’s medical device and pharmaceutical markets are estimated at over $800 million. Leading pharmaceutical companies, such as GlaxoSmithKline, Pfizer, Eli Lilly and Bristol-Myers Squibb, have established a presence in Singapore and continue to expand their facilities. Pfizer chose Singapore for its first large-scale active pharmaceutical ingredient manufacturing facility in Asia, while GlaxoSmithKline set up its first Asia region preclinical research establishment in Singapore. In response to the growth of Singapore’s medical industry, the Health Sciences Authority has been making great efforts to boost its regulatory expertise and improve the pharmaceutical and medical device regulatory environment in Singapore. Regulatory Bodies The Health Sciences Authority (HSA) was established in April 2001 to ensure the quality, safety and efficacy of drugs, medical devices, cosmetics, and other health-related products in Singapore. In January 2004, the Center for Drug Administration (CDA) was established under the HSA. The CDA was formed by merging two previously-existing agencies: the Center for Pharmaceutical Administration (CPA) and the Center for Drug Evaluation (CDE), which were both responsible for the regulation and evaluation of medical products in Singapore. The CDA’s mission is to further simplify and streamline the evaluation and registration processes of pharmaceuticals in Singapore. Pharmaceuticals Overview Medicines Act Product License
Application Process Pharmaceutical companies have the option of requesting a pre-submission consultation with the HSA. These requests should be made to the HSA in writing and a clear agenda and list of questions should be prepared by the company prior to the meeting. The information that the HSA provides is nonbinding and will not have a direct impact on the results of the application. New and variation product license applications are evaluated via one of three possible routes, depending on the type of product change. Pharmaceutical products which have not been approved by any regulatory agency will receive a full evaluation, which according to the CDA, takes approximately nine months to complete. If a product has already been approved by another country’s regulatory authority, an abridged evaluation process will be required, taking around six months to complete. Finally, if the product has already been approved by one of the principle regulatory agencies (US FDA, UK MHRA, Australia TGA, EU EMEA or Health Canada), only a verification evaluation will be necessary. This third evaluation process takes about six weeks to complete.
Overview The CMDR encourages medical device companies to voluntarily register their devices. This process allows both the industry members and government officials to become more familiar with the system and also address any potential complications or “hang-ups” prior to the implementation of the system. An application to register a device should be submitted by a local representative in Singapore, who is a natural or legal person established in the country, and has been specifically designated to act on behalf of the medical device company. Classification
System Medical Device
Register
Patent Bill
Amendment First, the amendment provides for flexibility in the patent term. In Singapore, after receiving a patent, the patent term begins even though the product has not been approved yet. Frequently, there are delays during the process of obtaining the market approval for a pharmaceutical in Singapore. In this case, a company could lose many weeks or months of the patent term since they are not yet able to market the product. Under the new amendment, the patent term will start once the product is approved. Second, Singapore is trying to preserve the balance between the interests of patent owners and users of pharmaceuticals by altering the parallel importation rules for pharmaceutical products. Under this new section of the Bill, a patent owner has special rights concerning parallel (generic or similar) products. Specifically, a patent owner is able to stop a parallel importer from importing a product that is a generic equivalent or similar to the patented product, if the product has not been previously sold or distributed in Singapore. But, once the patent owner imports the product into Singapore, this right will be voided – the patent owner may be subject to competition from parallel importers. There is one exception to the above regulation. If a patented pharmaceutical product is needed for the treatment of a specific patient in Singapore, the product may be parallel imported with the HSA's approval, regardless of whether the patent owner has brought the product into Singapore. This will ensure that Singaporeans receive adequate medical treatment and will not be denied treatment due to the lack of certain pharmaceutical products in the country. Finally, Singapore is improving its patent approval system through the creation of a two-track system. This system will better cater to a company’s needs, rather than the current one-track system, providing little flexibility. Track one is a “fast track,” which enables a patent applicant to expedite the application process and obtain a patent as soon as possible. The second process is the “slow track,” allowing a patent applicant to spend more time working on a marketing plan and patent strategy before entering the patent term. This new system should make the patent approval process more efficient and cost-effective by catering to each applicant’s needs. Subsidies for
Cardiac Treatment and Devices The MSP will provide subsidies for patients in Ward/Class B2 and C (which have six or more beds per room and do not have air conditioning). Patients in Wards A1, A2 and B1 (which have four or fewer beds per room as well as air conditioning) are not eligible to receive subsidies. The MSP will cover cardiac medical devices, procedures, investigations and even some cardiac drugs. These services are grouped into three categories and are based on medical necessity. (1) The Basic service includes standard healthcare services, where the indications are not controversial. (2) The Extended service refers to newer or more advanced medical services, some of which are controversial. Extended service is only required in special circumstances for certain patients; or in a case where the indications are still evolving. (3) Excluded service consists of non-essential medical services, like cosmetic surgery or experimental treatments. The main goal of the MSP is to ensure that patients are not “over-serviced” by healthcare providers. Therefore, the program has set up a system of peer review to make sure that patients receive the correct treatment, and are not subject to any unnecessary tests or treatment. However, the medical team in charge of treating a patient will make its treatment decision based on the patient’s needs, not the patient’s ability to pay. In the case where patients are still unable to pay their medical bills despite the subsidies, they will be referred to a medical social worker. New Guidance
on Disease Awareness Advertisements DAC advertisements should meet the following three requirements: (1) make no mention of any brand of medication, (2) do not promote any particular medicinal product or recommend consumers to ask their health professionals for any particular product, and (3) only provide factual, up-to-date and substantiated information. In the case where there is only one treatment option, or a new treatment has recently been released, companies must make certain that they continue to focus on the general education of the disease. The HSA will continually monitor DACs and has the authority to stop a DAC if it does not follow the above guidelines. Alternatively, companies may also indirectly advertise a particular prescription only medicine (POM), though this type of advertising cannot be done in the form of a DAC and requires approval from the HSA. The HSA released this new guideline to ensure that companies adhere to the DAC advertisement conditions as stated above, and do not attempt to indirectly advertise a POM in the form of a DAC advertisement. Updated Good
Distribution Practice (GDP) Guidelines for Pharmaceuticals Under the updated guidelines, some of the changes and new requirements are as follows. First, companies will be required to establish procedures for developing, controlling, and maintaining documentation related to the distribution process. The company should keep these documents up-to-date and have them readily available upon request. Second, if records are also maintained by electronic data systems, a detailed description and explanation of the system should be created. Any changes made to the data should be electronically recorded and can be used as reference information in the case of an audit. Third, companies will be required to develop an EEFO/FIFO system to help avoid distributing products with approaching expiration dates. Finally, anyone who distributes, trades, or stores APIs or intermediates in Singapore will need to maintain documents for tracing these products. Documents that allow for traceability should include the name and address of the original manufacturer, purchase orders, batch numbers, transportation information and Certificates of Analysis. New Good Distribution
Practice (GDP) Certification Guidelines A SMF should include the following nine sections: (1) General Information, (2) Personnel, (3) Premises and Facilities, (4) Stock Handling and Stock Control, (5) Documentation, (6) Product Complaints and Recalls, (8) Self-Inspections, and (9) Contract Activities. For instance, the General Information section should include practical data about the site, such as the location, contact information and number of employees. The applicant should also indicate whether the site has received approval from the home country health authority. In addition, the applicant must list all activities and operations carried out on the site, whether or not the activities are pharmaceutically-related. Under the Personnel section, job descriptions of the key employees should be included, as well as an explanation of any in-service training programs provided to the workers. When appropriate, images, drawings or layouts should be included, such as in the Premises and Facilities section. The SMF should contain approximately 25-30 pages of information in total, and may be submitted to the HSA in hardcopy or electronic format. New Guidance
on Minor Variation Applications for Pharmaceuticals The following are some of the changes categorized as MIV-1 variations: (1) manufacturing site, (2) shelf-life, (3) storage conditions, (4) packager, (5) testing procedures, (6) pack size, and (7) product labeling. These changes will require that specific documents (usually 5-10 documents) be submitted to the HSA for approval, prior to the change. MIV-2 variations require that a statement be submitted to the HSA only specifying the effective date of change, not requesting approval. This statement should be submitted at least two months prior to the implementation of the change and should be accompanied by supporting documents. MIV-2 variations include changes in the: (1) product owner, (2) manufacturer’s name or address, (3) name or address of the product license holder, (4) excipient, (5) composition of packaging material, (6) batch size, etc. Each minor variation must meet specific conditions in order to be categorized as an MIV-2 variation. If the conditions are not met, a MIV-1 application, requiring pre-approval, may be necessary. New Safety
Reporting Requirements for Pharmaceuticals Spontaneous suspected ADR refers to clinical observations of adverse reactions that originate outside of a formal study. Once a possible causal relationship is found between an ADR and the medicinal product in question, the license holder must submit a spontaneous suspected ADR report to the PV Unit of the CDA. This report must be submitted within 15 calendar days from the time any personnel of the license holder is made aware of the ADR. The report must be filed even if the license holder does not agree with the initial clinical observation. Periodic safety update reports (PSURs) may be requested by the CDA for certain kinds of registered medicinal products. License holders of selected medicinal products must submit a PSUR to the Product Evaluation & Registration Branch of the CDA every 6 months for the first two years after market approval. After two years have passed, a PSUR must then be submitted yearly for the next three years. The CDA recommends that license holders of products not requiring a PSUR still maintain a summary report on safety data. If the CDA requests this kind of report it must be submitted within 30 calendar days. If safety concerns cause regulatory actions to be taken by other regulatory authorities, or actions to be taken by the product owner itself, the license holder must notify the PV Unit of the CDA within 7 days. Significant safety concerns that require reporting include: product withdrawal/recall, removal of approved indications by regulatory agencies, failure to obtain product license renewal, etc. Reports of this nature must describe the safety related reasons why actions were taken, review the consequences of the actions taken and also include recommendations on follow-up actions to be carried out locally.
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