It contains the drug application, registration and approval of drugs in Singapore.

1. ASEAN
By;
VENUGOPAL N
1ST M-Pharmacy
Pharmaceutical Regulatory Affairs
JSSCP, Ooty.

2. INTRODUCTION
• ASEAN was established on 8 August 1967 in Bangkok by the five original
member countries Indonesia, Malaysia, Philippines, Singapore and Thailand.
• On 8 January 1984 Brunei Darussalam joined ASEAN.
• Vietnam on 28 July 1995
• Laos and Myanmar on 23 July 1997
• Cambodia on 30 April 1999.
• In 1999 a harmonization initiative was started among the 10 ASEAN countries.

3. ASEAN
COUNTRIES
 VIETNAM
 THAILAND
 MALAYSIA
 CAMBODIA
 INDONESIA
 SINGAPORE
 BRUNEI
 MYANMAR
 LAOS
 PHILIPPINES

4. SINGAPORE

5. INTRODUCTION
Singapore is a small city-state with a land area of 683 sq km and a
resident population of 4.9 million.
The three major ethnic groups are Chinese (77%), Malays (14%) and
Indians (8%) .
The significance of Singapore to the pharmaceutical product is not due
to its market size but for the more manufacturing and use of bio-
medicinal products (pharmaceutical and medical devices).

6. • Full name: Republic of Singapore
• Population: 5,469,700 as of 2014
• Capital: Singapore
• Area: 718.3 square kilometres
• Major language: Spanish
• Religion: Christianity
• Currency: Nuevo sol (PEN)
• Calling code:+65
• Regulatory Authority: Health Sciences Authority (HSA)

7. Pharmaceutical products in Singapore are regulated by many
laws and regulations, the main legislative framework includes,
MEDICINES ACT enacted in 1987 to ensure marketed drugs
are of appropriate standards (safety, quality and efficacy)
HEALTH PRODUCTS ACT enacted in 2007 to comply the
appropriate standards of cosmetics, traditional medicines and
health products.

8. HEALTH PRODUCTS REGULATION
• The Health Products Regulation Group ensures that drugs, innovative
therapeutics, medical devices and health-related products in Singapore are
regulated to meet required standards of safety, quality and efficacy.
• The Group comprises the Pre-marketing Division (Western Medicine,
Medical Devices, Complementary Health Products and Cosmetic Products
branches), Post-marketing Division (Vigilance, Compliance Enforcement
and Medical advertisement branches), the Audit and Licensing branch, and
the Group Director‘s Offices.

9. MEDICINAL PRODUCT REGISTRATION
Under the Medicines Act, a "medicinal product" refers to any substances or
article, which is manufactured, sold, supplied, imported or exported for use
mainly in the following ways:
Use by being administered to one or more human beings for a medicinal
purpose;
Use as an ingredient in the preparation of a substance or article which is to be
administered to one or more human beings for medicinal purpose.

10. CORPORATE PROFILE
The Health Sciences Authority (HSA) was formed on 1 April 2001 as a
statutory board of the Singapore Ministry of Health with the integration of
five specialised agencies:
1. Centre for Drug Evaluation
2. Institute of Science and Forensic Medicine
3. National Pharmaceutical Administration
4. Product Regulation Department
5. Singapore Blood Transfusion Service

11. • Its vision is to be the leading innovative authority protecting and advancing
national health and safety.
• Restructured into three main groups, the Health Products Regulation Group, the
Blood Services Group, and the Applied Sciences Group,
HSA carries out its mission:
• To wisely regulate health products to meet standards of safety, quality and efficacy
• To serve the administration of justice through its capabilities in forensic medicine,
forensic science and analytical chemistry testing
• To secure the nation’s blood supply by ensuring a safe and adequate blood supply
for public and private hospitals

12. PRODUCT LICENSE
• Product license is required before a medicinal product can be sold or
supplied in Singapore.
Each product license is specific to a product:
• Of a particular name;
• With a particular formulation;
• In a particular dosage form (i.e. physical presentation) and strength;
and
• With a particular set of approved indications and directions for use.

13. FORENSIC CLASSIFICATION:
Medicinal products approved for registration in Singapore are classified under three
forensic classes:
1.Prescription Only Medicine (POM);
2.Pharmacy only medicine (P); or
3.General Sale List medicine (GSL).

14. Prescription only product Pharmacy only product General sales list Medicines
Considered as dangerous for
self-use and requires supervision
of Doctor, Dentist, and
Pharmacist.
Not dangerous enough to be
categorized as prescription
product.
Requires instruction only from
the Pharmacist.
Generally safe and can be sold
without supervision of Doctor,
Dentist, Pharmacist.
The contraindications being
complex are not properly
understood by the patient and
requires application
The contraindications are not
easily understood by the patient
and require instructions from
the Pharmacist.
The contraindications are very
easy to understand by the
patient.
Special precautions and the
intensity of the care required is
more as in this case.
Special precaution is needed in
the storage and handling of the
product.
Hazard to health, risk of misuse,
risk of improper diagnosis, need
to take special care are less.

15. REGISTRATION PROCESS
One part of a product's life cycle is the pre-marketing activities, namely registration of a
product prior to market entry.
The registration process involves a series of steps:
PRE-SUBMISSION PREPARATION
APPLICATION SUBMISSION
APPLICATION SCREENING
APPLICATION EVALUATION
REGULATORY DECISION
POST-APPROVAL CHANGES

16. PRE-SUBMISSION STAGE INVOLVES THE
FOLLOWING ACTIVITIES:
The first step in the registration process is one of the most important
because it involves
• Knowing which application to apply for;
• Knowing which evaluation route to choose; and,
• Arranging for a pre-submission consultation with HSA for advice, if
required.

17. TYPES OF APPLICATION
• In applying for a new Product License for a medicinal
product in Singapore, there are two categories of
applications:
• A New Drug Application (NDA) and
• A Generic Drug Application (GDA):

18. NEW DRUG APPLICATION
NDA-1;
Is applicable for first strength of product containing new chemical, or biological entity.
NDA-2
For the first strength of a New Product:-
• Containing a new* combination of registered chemical or biological entities;
• Containing registered chemical or biological entity(ies) in a new dosage form;
• Containing registered chemical or biological entity(ies) for use by a new route of administration;
• Containing registered chemical or biological entity (ies) for new indication(s), dosage
recommendation(s) and/or patient population(s).

19. NDA-3:
For subsequent strength(s) of a new drug product that has been registered,
or has been submitted as NDA-1 or NDA-2.
Generic drug application
• GDA -1: for the first strength of the product.
• GDA- 2: for the subsequent strengths of the products of generic chemical
product that has been registered or has been submitted as GDA 1.
The product name and pharmaceutical dosage form shall be in the same
as that for the GDA-1.

20. APPLICATION SUBMISSION:
Application submission comprises of two parts:
1.Prism application form,
2.Registration dossier.
PRISM APPLICATION form is for on-line submission of applications.
Registration dossier is submitted to support the evaluation of the submitted application.
While submitting the dossier the applicant has to attach the printout of the Prism application
form.
REGISTRATION DOSSIER:
The complete dossier should be submitted within 2 working days after the prism application
submission to prevent the delay in the processing of the application.

21. LANGUAGE
Information & documents supporting an application such as certificates
approval letters should be in English.
AUTHENTICATION OF DOCUMENTS
• Required for Foreign Documents. Not Required if seal of the country is
present.
• Certification of Non Original Documents. – Should be done in presence of
Attorney, or in Consulate.

22. APPLICATION SCREENING
• After PRISM and dossier submission, the application will be screened to
ensure that the correct application type has been chosen and that there are
no deficiencies that would delay the registration process.
• If the application type needs to be re-categorized, for example from NDA-2
to NDA-3 or GDA-1 to NDA-2, the applicant will be notified and
subsequently, the PRISM application will be amended.

23. • If any deficiencies are identified, a screening query letter via Input
Request will be issued to the applicant.
• The stop-clock starts whenever HSA requests for clarification or additional
information.
• The stop-clock ends when HSA receives a complete and satisfactory
response to the query.
• The applicant will be required to submit all of the requested information
and documents within 30 calendar days from the date of the screening
query letter. Any deficiencies noted must be addressed before the dossier
can be accepted for evaluation.

24. APPLICATION EVALUATION
• Upon acceptance of an application, evaluation by HSA is based on the data set
submitted by the applicant. A query letter will be issued to the applicant if
clarification or additional information is required. The stop-clock starts whenever
HSA issues a query letter and ends when HSA receives a complete and
satisfactory response from the applicant.
• If the applicant anticipates difficulty in responding in full or within the specified
timeframe, then HSA should be contacted to discuss the request for information as
soon as possible after receipt of HSA‟s query letter. An application will be
considered withdrawn if the stop clock time exceeds the deadline agreed upon by
HSA and the applicant.
• Additional supporting data submitted after acceptance of the application will not
be considered, unless requested by HSA or mutually agreed upon by HSA and the
applicant prior to acceptance

25. REGULATORY DECISION
A regulatory decision is made based on the outcome of HSA‟s evaluation of the submitted
data package.
Applicants will be notified by letter of one of the following outcomes:
• Approval – the application has satisfied the registration requirements for quality, safety
and efficacy;
• Approvable – when the application has minor deficiencies;
• Non-approvable – when the application has major deficiencies; or
• Rejection – when the response provided by the applicant fails to address the major
deficiencies highlighted in HSA‟s non-approvable decision.
Approval and rejection are final decisions issued by HAS.