Pharmaceutical and API Product Registration in the Other Asian Countries

Southeast Asia:

Pharmaceutical and API Product Registration in the Other Asian CountriesDoes your company need pharmaceutical product approval in one or more Asian countries? Pacific Bridge Medical’s compliance and regulations expertise will help you navigate the Asian regulatory systems, achieve drug product registration, and access the expanding Asian medical markets. You can rely on us to move your drug or API product forward quickly and efficiently in the registration and approval process.

Hong Kong Pharmaceutical Registration and Approval

Under Hong Kong’s Department of Health (DOH), the Pharmaceuticals Service Department of Health (PSDH) regulates pharmaceuticals/drugs.

All drugs must be registered with the Pharmacy and Poisons Board prior to being sold in Hong Kong. The registration process requires the attachment of several certifications to the product registration application, including a Free Sales Certificate from the country of origin, the manufacturer’s license, a Good Manufacturing Practice (GMP) certificate, etc. In addition, a completed checklist must be submitted with the applicable registration and application fees.

Taiwan Pharmaceutical Registration and Approval

The Ministry of Health and Welfare (MOHW) established the Taiwan Food and Drug Agency (TFDA) to implement/apply pharmaceutical regulations. The TFDA is Taiwan’s equivalent of the U.S. FDA. Obtaining TFDA approval is a mandatory requirement for all pharmaceutical imports marketed in Taiwan.

Aimed at foreign manufacturers in particular, the functionality of Taiwan’s pharmaceutical registration process is well-known for its lengthy and time-consuming nature. In certain instances, consultation(s) with the MOHW consultation is a critical step in deeming whether the requirement for clinical trials or bridging studies exist.

Subsequently, American pharmaceutical companies and trade associations pursued negotiations with the Taiwanese government to instigate a more streamlined drug approval process. Recent MOHW regulation revision efforts simplified the review process, sequentially increasing the number of high quality, foreign manufactured drugs entering the Taiwanese market. For instance, Taiwan adopted the Pharmaceutical Inspection Co-operation Scheme (PIC/s) with regard to the PMF; and a Drug Master File (DMF) system, allowing foreign drug manufacturers to register pertaining manufacturing/quality procedures of their APIs to the TFDA. Lastly, for certain drugs, U.S. or EU approvals are now acceptable substitutions for some local requirements.

Pharmaceutical Registration in the ASEAN Markets

Since 2009, the ASEAN Consultative Committee for Standards and Quality Pharmaceutical Product Working Group (ACCSQ PPWG) began developing a harmonization initiative with the intent of (1) creating a transparent regulatory process, (2) standardizing regulation requirements, and (3) removing the need for duplicate studies to meet various regulation requirements, thereby allowing drug companies more time and resources that can be used towards research and development of new drugs. With this harmonization initiative, drug companies can adhere to one set of regulatory requirements for all ASEAN countries.

The drug company must follow the ASEAN common technical documents (ACTD) to be certified as compliant. While seemingly straightforward, the drug approval process is still not consistent across all ASEAN countries. For example, only about 5% of the drug industry in the Philippines is compliant with the ACTD.

Indonesia Pharmaceutical Registration and Approval

Indonesian product registration is regulated by the National Agency of Drug and Food Control (NA-DFC), which is responsible for evaluating the efficacy, safety, risk, quality, and health demands of the Indonesian population.

As a result of Indonesia’s strict regulations on pharmaceutical product registration regulations, the majority of drugs approved must be domestically manufactured. Foreign companies should occupy their own production plant or partner with a local company.

There are four pharmaceutical categories: over the counter (OTC) products (Category F), prescription drugs (Category G), narcotics (Category O), and OTC products with warning labels (Category W). Registrants must submit application documents that can include the drug master file, a manufacturing license, GMP certificate and manufacturing site master file. Application submissions should be in compliance with ASEAN Common Technical Documents (ACTD). ASEAN standards for GMP, clinical studies, stability studies, etc. should be followed. The timeline for drug registration is typically between 1-3 years.

Malaysia Pharmaceutical Registration and Approval

The Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH), oversees drug registration.

In Malaysia, many high-end drug products are imported. Robust government spending on healthcare and attractive government tax incentives for foreign drug companies operating in Malaysia leads to increased growth and opportunities for prospective foreign pharmaceutical companies.

Applications can be submitted to the DCA online via the Quest 2 system. There are 4 categories of pharmaceuticals in Malaysia: biologics, new drug products, over the counter (OTC) generics and generics. Although certain types of OTC products are eligible for an abridged evaluation, all other pharmaceutical products must undergo an entire evaluation via the DCA prior to approval. The estimated timeline for abridged evaluations is around 180 days; full evaluations can extend up to a year or more. Registrations are valid for 5 years and can be renewed.

The Philippines Pharmaceutical Registration and Approval

The Philippines FDA, under the Department of Health, is the primary government agency overseeing pharmaceutical/drug registration and regulations. All imported pharmaceuticals must be registered with the Philippines FDA prior to market entry.

Foreign drug companies account for a substantial percentage of the Filipino pharmaceutical market. Furthermore, with the implementation of universal healthcare, sales growth opportunities for foreign drug companies should increase considerably.

Singapore Pharmaceutical Registration and Approval

The Singaporean regulator of pharmaceuticals is the Health Sciences Authority (HSA). The Therapeutic Products Division of the HSA is accountable for reviewing and approving pharmaceuticals; their subdivision is the Pharmaceuticals & Biologics Branch.

All drugs require a product license prior to being imported or sold in Singapore. When applying for a product license, dossiers must comply with the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format or the ASEAN Common Technical Document (ACTD) format.

For new product licenses, Singapore requires a new drug application (NDA) and a generic drug application (GDA). For products previously approved by certain regulatory agencies (e.g. Australia’s TGA, US FDA, etc.), submitting an abridged dossier is a possible option. Applicants submit an online application and CTD dossier through PRISM (Pharmaceutical Regulatory and Information System).

Thailand Pharmaceutical Registration and Approval

The Thai FDA (TFDA), one of several agencies under the Ministry of Public Health (MPH), is the regulatory body administering drugs in Thailand. The Drug Control Division of the TFDA is responsible for registration, licensing, surveillance, inspection and adverse event monitoring for all pharmaceuticals and pharmaceutical companies in Thailand. Foreign pharma companies dominate the Thai drug market. Due in part to trade negotiations, regional harmonization and positive economic trends, the pharmaceutical market in Thailand is predicted to double by 2022.

There are several versions of the Drug Act currently in effect, and the Thai government is working on a revised version with updated regulations. Under the current laws, pharmaceuticals are categorized as either traditional or modern medicines, with different applications and oversight. Modern medicines are subdivided into three categories, each of which has separate registration requirements. Licenses currently do not require renewal.

Vietnam Pharmaceutical Registration and Approval

The chief regulatory authority in Vietnam is the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV). In 2013, the MOH authorized The Provincial Department of Health to grant certificates for foreign-owned enterprises’ drug manufacturing, drug maintenance, drug testing and import of drugs.

Vietnam’s regulatory environment can often be unclear and inconsistent. Regulations are frequently implemented on a case-by-case basis, with little overall coordination. The majority of the product application can be completed in English. The documents required with the drug application package include: Free Sale Certificate from the country of origin, GMP certification, product information, a detailed description of the manufacturing process, quality specifications, finished product samples, packaging information including a Vietnamese language insert leaflet etc. Upon the application review and approval, the timeline for the approval license (locally known as a visa) process is roughly about six months, however, drug approval times vary and delays can be expected.

In an effort to control rising drug prices, the Vietnamese government requires that pharmaceutical import licenses disclose the price of the product. Local expertise is beneficial in avoiding or limiting government price restrictions.

Ready to achieve registration approval for your pharmaceutical product in your target Asian market? Contact us today to discuss your needs with our expert regulatory consultants.

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