FAQ GENERICS

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GENERIC PRODUCTS

1.      What are Generic Products?

Answer: A generic product is a product that is essentially similar to a currently registered product in Malaysia. However, the term generic is not applicable to biologic products.

Generics may be further classified into two groups:

i. Scheduled Poison(Known as Controlled Medicine/ Controlled Poison)

· Products containing poisons as listed in the First Schedule under Poisons Act 1952.

ii. Non-scheduled Poison (Known as Non-Poison or “Over-the-Counter”, OTC)

· Products containing active ingredients which are not listed in the First Schedule under Poisons Act 1952; and is excluding active ingredient which is categorized under health supplements or natural products or cosmetics.

 

2.      If there are more than one source of Active Pharmaceutical Ingredient (API) , does the stability data for finished product for all sources need to be submitted?

Answer:  No. The stability data for batches from one of the API sources will suffice.

 

3.      What is the guidance document  for stability studies of finished products to be registered in Malaysia?

Answer: The ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG) which can be found on the NPRA website www.npra.moh.gov.my/. Please search the relevant guidelines under ASEAN Guidance Documents.

 

4.      What are the guidance documents for Process Validation of finished products to be registered in Malaysia?

Answer: The ASEAN Guidelines on Process Validation which can be found on the NPRA website www.npra.moh.gov.my/. Please search the relevant guidelines under ASEAN Guidance Documents.

 

5.      What are the bioequivalence requirements for the purpose of product registration submission in Malaysia?

Answer: Kindly refer to NPRA website www.npra.moh.gov.my/. Kindly click Industry --> Generic Medicines --> Bioequivalence (BE)

 

6.      Where is the list of Malaysia comparator products (MCP) for applications with bioequivalence studies?

Answer: Kindly refer to NPRA website www.npra.moh.gov.my/ --> Industry --> Generic Medicines --> Bioequivalence (BE) --> Generic Product List for BE studies --> Refer to the related list to search for the reference product(s)/ comparator(s).

 

7.      What is the basis for a product to be categorised as Abridged Evaluation, Non Scheduled Poison/OTC products?

Answer:

Non Scheduled Poison Abridged Evaluation is for low risk pharmaceutical products based on these 3 factors:

i. Active ingredient - contains well established active ingredients

ii. Dosage form and route of administration: external preparations and locally acting dosage forms

iii. Indication: used for non-critical conditions only (eg acne, dandruff, counterirritant, antiseptics).

 

Currently, there are 11 categories of products listed in DRGD that are classified as Non Scheduled Poison Abridged Evaluation.

 

No

Category

Examples

Active ingredient(s)

1.

Antiseptics/ skin disinfectants

* For use on the human body

Dettol Antiseptic Liquid, Eusol Solution

isopropyl alcohol, ethyl alcohol,  chlorhexidine, povidone-iodine, acriflavine, chloroxylenol, cetrimide

2.

Locally-acting lozenges/ pastilles

Sore throat/ cough lozenge eg Strepsils, Fisherman Friend lozenge

dequalinum, menthol, amylmetacresol, dichlorobenzyl alcohol, hexylresorcinol

3.

Topical analgesic/ counter-irritants

Cream/ointment /gel for muscle and joint pain (muscle rub, 'minyak angin')

menthol, camphor, methyl salicylate, capsaicin

4.

Topical nasal decongestants

Vicks Nasal Inhaler

menthol, camphor, eucalyptus oil

5.

Emollient/ demulcent/ skin protectants

Aqueous cream,

Calamine lotion

calamine +/- zinc oxide

6.

Keratolytics

Wart and anti-corn solution

salicylic acid, sulfur, urea

7

Anti-dandruff

 

coal tar

8

Oral care

Antiseptic mouthwash/gargles

povidone-iodine, thymol, chlorhexidine, hexetidine, cetylpiridinium

9

Anti-acne

 

salicylic acid, triclosan, benzoyl peroxide, resorcinol

10

Medicated plasters/ patch/ pad

 

menthol, camphor, methyl salicylate, glycol salicylate, povidone-iodine, acriflavine

11

Topical antibacterial

Antiseptics, anti-acne

 

Besides these categories, other Non Scheduled Poison products will undergo Full Evaluation including topical anti-scabies/lice, topical anti-psoriasis/eczema and topical antifungals products.

 

8.      What is the difference in the registration requirements between the Abridged and Full Evaluation for Non Scheduled Poison/OTC products?

Answer: In general, the Abridged Evaluation has simplified registration requirements compared to the Full Evaluation. This category is exempted from certain information in Part I ACTD and Process Validation Report as tabulated in the table below. In addition, Abridged Evaluation does not require Quality Control pre-registration documentation such as the protocol of analysis (PoA) and analytical method validation (AMV) report. However, PoA still needs to be submitted to NPRA for the purpose of post-market surveillance testing after the product is registered.

Other than these exemptions, the registration requirements of Abridged Evaluation are the same as Full Evaluation such as the PICS GMP, CPP for imported products, labeling, package insert/RiMUP, certificate of analysis, Zone IVb Stability Data etc.

Product Categories

Registration Requirement

Exemption

Generics, Non-Scheduled Poison (X), Full Evaluation

Part I ACTD

Part II ACTD

DP - BA/BE Study for MR only + lab evaluation

DS (unregulated API, minimum requirement)

DP – BA/BE Report requirement for IR

Generics, Non-Scheduled Poison (X), Abridged Evaluation

Part I ACTD

Part II ACTD

DP  - BA/BE Study for MR only

DS (unregulated API, minimum requirement)

Part I ACTD – PD, PK, P&L

DP - PV Report

Lab evaluation - AMV Report, PoA

 

ACTD : ASEAN Common Technical Dossier

DP : Drug Product

DS : Drug Substance

MR : Modified Release Oral Dosage Form

IR : Immediate Release Oral Dosage Form

BA/BE : Bioavailability/Bioequivalence

PD : Pharmacodynamic

PK : Pharmacokinetic

P&L : Pregnancy and Lactation

PV : Process Validation

AMV : Analytical Method Validation

PoA : Protocol of Analysis

 

9.      What are the drug substance(DS) / Active Pharmaceutical Ingredient (API)  registration requirements for Non Scheduled Poison/OTC category?

Answer:  Regulatory control of DS/API  has yet to be implemented for Non Scheduled Poison products.

Only minimum requirement for DS/API is required as below :

· S1.1 Nomenclature

· S1.2 Structure

· S1.3 General Properties

· S2.0 API Manufacturer

· S4.1 Specification (API)

· S4.2 Analytical Procedures (API)

· S4.4.1(i) CoA (API) - from API Manufacturer

· S4.4.1(ii) CoA (API) - from Product Manufacturer

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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