Pharmaceutical Regulations and Registration in Singapore

Selling and exporting of the New or Generic drugs can be only done after obtaining a valid product license through registration. The application for license needs to be submitted to the Singapore Health Sciences Authority (HSA) and requires common technical document (CTD) format which is designed by ICH (International Conference on Harmonization). The manufacturer or import should have ICH designed Association of Southeast Asian Nations (ASEAN).

Pharmaceutical Products Market in Singapore

Singapore stands on 6th position in healthcare system worldwide and is one of the leading pharmaceutical or biomedical hubs in Asia since they took the initiative of government’s Biomedical Sciences (BMS) launched in 2000. Singapore spends its 4.7% of GDP on healthcare. The healthcare industry in Singapore is expected to grow at 6.40% of CAGR till 2030.

6% of World’s total OCT Drugs are produced in Singapore and it is expecting a 48% of revenue share in pharmaceutical market by 2024. Growth of Singapore’s pharmaceutical industry is contributed by several factors such as adopting modern technology and development of reliable and cost effective medical services. The industry has significantly benefited through the funding support by government in Research and development on biomedical and related sciences. Singapore’s pharmaceutical exports supersede the import and continue to grow.

Drug Classification in Singapore

Based on products:

• Generics
• Over-the-Counter (OTC Drugs)
• Patented drugs

Based on therapeutics:

• Infectious diseases
• Cardiovascular diseases
• CNS Disorders
• Oncology
• Respiratory Diseases
• Diabetes
• Gastro-intestinal diseases
• Dermatology, Rheumatology and other diseases

Based on regulatory classification:

• Prescription only medicine (POM)- Sold only by prescription
• Pharmacy only medicine, 1st Schedule (P)- sold in pharmacy under the pharmacist supervision
• Pharmacy only medicine, 2nd Schedule (P+)- sold in pharmacy under the pharmacist supervision but under certain conditions given in schedule.
• General sales list (G)- Sold to the consumer without any restrictions

How are Drugs Regulated and Approved in Singapore?

Selling and exporting of the New or Generic drugs can be only done after obtaining a valid product license. The application for license needs to be submitted to the Singapore Health Sciences Authority (HSA) and requires common technical document (CTD) format which is designed by ICH (International Conference on Harmonization). The manufacturer or import should have ICH designed Association of Southeast Asian Nations (ASEAN).

The Applicant should know the type of product application and route for the evaluation of the drug in case of therapeutic products and the applicant need to attend HSA pre-submission consultation which helps in differentiating the drug between chemical and biological therapeutic products. In Singapore classifies the application into two categories which are NDA (New drug Application) and GDA (Generic Drug Application). GDA Applies to the chemical and does not apply to the biosimilar drugs (Submitted via NDA).

Which Authorities Regulate Drugs In Singapore?

1. Ministry of Health
2. Association of southeast Asian Nations (ASEAN)
3. Health Products Act – It regulates the registration, supply, import, manufacture, storage, packaging and advertising of the products including therapeutics, cosmetics and medical devices in Singapore.
4. Health Sciences Authority (HSA) – The key authority and multi-disciplinary agency in Singapore which regulates the drugs jurisdiction of medical and biological drugs.

Registration of Pharmaceutical Products In Singapore:

Here you can understand regulatory requirements for pharma registration in Singapore. A Step-by-step process under HSA for dossier, review, and approval.

HSA Pre-registration Requirements:

The following are some of the pre-registration requirements for pharmaceuticals in Singapore:

• The product’s company must be registered in Singapore.
• If foreign manufacturer, they must appoint a local representative in Singapore.
• The manufacturer must have a valid pharmaceutical license approved by the Health Sciences Authority (HSA) or any other foreign body.
• Check your product classification, and if you have any trouble or confusion to classify your product get your product classified from the HSA before its registration.
• Schedule pre-registration meetings with HSA, to solve regulatory queries, if any.

List of Documents Required by HSA:

During the registration process of pharmaceutical products, the following documents may be required:

• Product information, including composition, manufacturing process, and specifications.
• Stability data.
• Clinical trial data (if applicable).
• Bioequivalence data (for generics).
• Quality testing data.
• Packaging and labelling information.

Process of Drug Registration by HSA

Therapeutic Drug Registration:

It is extremely important to find the type of application of the drug which is to be registered via registration guides. There are two types of applications which are-

I. New Drug Application (NDA)

II. Genetic Drug Application (GDA)

HSA regulates the generic drugs and handles the registration of pharmaceutical products. The importer should have a person as registrant from Singapore which will be responsible for quality of the product and applicant needs to have a local company in Singapore which is registered with Accounting and Corporate Regulatory Authority (ACRA).

PRISM- The drug application in the ICH CTD format is registered through the online/electronic/e-service platform which is generally known as PRISM (Pharmaceutical Regulatory and Information System). E-service gives convenience to customers and authority.

They can only be registered after the evaluation of the drugs. There are 3 routes of evaluation which are-

I. Verification route

II. Abridged route

III. Verification evaluation route (CECA Scheme)

Notification process

After the approval of the application, if the HSA finds that the application is satisfying the requirements of quality and safety, the product is included in the therapeutic products register by the authorities.

CPP (Certificate of Pharmaceutical product) is issued for registered or un-registered products which are to be exported or evaluated. The therapeutic product needs to be manufactured under the quality compliance according to the GMP Standards mandated by WHO.

New Drug Application (NDA) (HSA)

These drugs are composed of new chemical and biological entities. NDA covers therapeutic products under 3 categories;

• NDA 1- First strength of new chemical or biological entity which are currently not existed or registered in Singapore.
• NDA 2- Products which do not fall in NDA-1,NDA-3 OR GDA products and first strength products, or the products which are registered by the new route of administration or patient population, new indication and dosage recommendation.
• NDA 3- Subsequent strength of products which are already registered and the product name, dosage and patient population should be same as NDA-1 and NDA-2 submission.

Biosimilar Products-

They are therapeutic products which are very similar to existing biological products in physicochemical characteristics, safety, and biological activity. These products are submitted via NDA-2 or NDA-3.

Generic Drug Application(GDA)

This application applies to the therapeutic product which consists of one or more chemicals. The GDA Application can only be registered if the drug meets the criteria which should be according to Singapore reference products. There are 2 types of GDA Application to register and market the drugs in Singapore;

• GDA 1 – First strength of generic chemical product submission.
• GDA 2- Subsequent strength of generic product which is already submitted as GDA-1 and the product and dosage should be same as first strength product.

Timeline for registration of drugs by HSA-

NDA: It takes 50 days for screening application for all the evaluation routes but the evaluation time for different routes is between 60- 270 days.

• 60 days- verification evaluation routes
• 180 days- Abridged evaluation
• 270 days- Full evaluation time

GDA: It takes about 50 days for the screening of the application which starts from the day when the registrant receives the receipt for the application dossier and the screening time can be increases if the applicant needs to provide any clarification or additional document. Given below are the time taken for the evaluation of drugs.

• 120 days- Verification evaluation route
• 90 days – Verification evaluation route (CECA scheme),
• 14 days – Verification evaluation route first communication.
• 240 days – Abridged evaluation route.

Labeling Requirements for Pharmaceutical Products in Singapore:

The following information must be written on the label of pharmaceutical products:

1. 1. 1. All the information on the label must be written in English language.
      2. The outer packaging label should include the following aspects on its label:
         • • Product name with its strength.
           • List all the ingredients with their concentration.
           • Batch.no
           • Manufacturing and Expiry date
           • Storage conditions
           • Administration instructions
           • Precautions if any
           • Product registration number
           • Name of the manufacturer
      3. All the information written on the outer packaging should be written on the inner package also, but if space does not permit include atleast the given information on the inner package:
         1. • Product name
            • Ingredients with their concentration
            • Batch number
            • Manufacture date
            • Expiry date
            • Route of administration
            • Registrant name
      4. The product must contain an information leaflet and should cover all the manufacturing details and consumption instructions in detail.

Pharmaceutical Clinical Trial Requirements in Singapore:

Following are the clinical trial requirements for therapeutics in Singapore:

• Before the initiation of clinical trial, authorization for clinical trial should be taken from the ethics committee.
• A detailed application including all the aspects of clinical trials, investigational drug, procedures and people involved in trials should be included in the application.
• The clinical trial should comply with the Good Manufacturing Practice (GMP) guidelines.

Pharma Testing Requirements in Singapore:

Therapeutics in Singapore should undergo detailed testing to evaluate their safety and quality standards.

• Quality aspects such as impurities, stability studies are dissolution factors are evaluated.
• Bioequivalence studies are conducted and evaluated.
• Pharmacokinetics studies which involve the study of absorption, distribution, metabolism and excretion are conducted and evaluated.

Pharma Products Foreign Testing:

Foreign testing data from recognized authorities such as US Food and Drug Administration (FDA) or (European Medicines Agency) EMA are accepted in by Singapore authorities and do not require additional testing.

But the testing should comply with the HSA regulations.

Import and Distribution Requirements:

For import of pharmaceuticals in Singapore the manufacturer must possess a valid import license from the HSA.

For distribution of therapeutics, the distributor must comply with the GDP guidelines.

GMP Inspection Requirements:

In order to guarantee adherence to Good Manufacturing Practices, HSA carries out inspections of pharmaceutical manufacturing facilities. These inspections evaluate the quality management systems, manufacturing processes, and compliance with regulatory standards.

Post-Marketing Activities in Singapore:

Following the product registration, pharmaceutical companies in Singapore are obligated to fulfil a range of post-marketing responsibilities, which include:

• Frequent audits and inspections should be carried out.
• The pharmacovigilance system should keep track of the adverse events that occur due to the therapeutic product.
• Any changes to the product should be immediately reported to the HSA and without its compliance should not be sold in the market.
• The product approval should be renewed before its expiry.

Conclusion:

The compliance of therapeutic products in Singapore is handled by the HSA. Hence to successfully launch your pharmaceutical product in the Singapore market, the manufacturer must ensure compliance with the HSA.

For a smooth registration of your pharmaceutical product with the HSA in Singapore, partner with Artixio. We, with our experienced localized team members, ease your regulatory journey achieving timely compliance and making your product successful.

Contact today at info@artixio.com

FAQs:

1. Do generic drugs require registration in Singapore?

Yes, generic products do require registration in Singapore with the HSA authority, before they are marketed.

2. What is the fast-track process of approval in Singapore for drugs that requires immediate approval in case of rare diseases treatment?

The HSA has a special expediated process for the approval of medicines for treatment of rare diseases or any serious conditions that require medications on an urgent basis. This fast-track process is known as PRIME scheme and within this scheme the drug is approved within 120-180 days.

3. What is special access route (SAR) In Singapore?

The special access route (SAR) in Singapore allows unregistered medicines to be used for special clinical cases. This scheme allows both imported and local unregistered drugs to be used in Singapore.

4. How frequent should the product license be renewed in Singapore?

The product license should be renewed once in every 5 years as the validity of the product license is 5 years in Singapore.