ABRIDGED EVALUATION OF 

OTC PRODUCTS  Ministry Of Health Malaysia

– MALAYSIA EXPERIENCE 
MS ISO 9001:2008 Certified

SELF-CARE CONFERENCE AND 2nd SELF-CARER

ROUND TABLE
Member of Pharmaceutical
Bangkok, Thailand Inspection Cooperation
Scheme
17th September 2015

Anis Talib
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Jalan Universiti 46730 Petaling Jaya
MALAYSIA WHO Collaborating
Centre
Tel : 603-78835400 Fax : 603-79562924
For Regulatory Control of
Website : www.bpfk.gov.my Pharmaceuticals
 PRESENTATION OUTLINE
 Introduction
 OTC ­ Abridged vs OTC Full Evaluation

 Fees, Timeline, Registration Process & 
Requirements
 Issues & Challenges

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INTRODUCTION

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 GENERIC PRODUCT
 A product that is essentially similar to a currently
registered product in Malaysia. The term generic is not
applicable to biologic products.

1) Scheduled Poison:
 Known as Controlled Medicine/ Controlled Poison
 Pharmaceutical products which contain scheduled
poison(s) as listed in the First Schedule under the
Poisons Act 1952.

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2) 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
categorised under health supplements or natural
products or cosmetics

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 REGISTRATION PHASES
NEW PRODUCTS Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6
BIOTECHNOLOGY Regulatory
Registration control of
Registration Registration Registration Registration
Jan 1992 Active
Aug 1985 1988 Feb 2002 Aug 2007
(Traditional Pharmaceutic
(Prescription (OTC) (Cosmetics) (Veterinary)
Medicine) al Ingredient
Drugs)
(API)**
VETERINARY
No licensing
MEDICINE
Licensing Requirements
Licensing Licensing Manufacturer Licensing Licensing as
May 1987 1992 Importers Jan 2004 1 July 2012* registration of
Jan 1999 API is linked
to products
ACTIVE 
PHARMACEUTICA Licensing
L INGREDIENTS Wholesalers Surveillance Surveillance
Surveillance
Surveillanc Surveillance
Surveillanc Surveillance Surveillance
July 2002  (to be 
(to be  (to be 
1990
e 1990 e1995
1995 2005
Surveillance announced)
announced) announced)
2000

1st January 2008 – Registration of Cosmetics replaced by 
NOTIFICATION
* 1
st
 July 2012:
All manufacturers shall be certified for GMP as directed via Directive Arahan di Bawah 
Peraturan 29, Peraturan­peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 1 Tahun 2012 6
** Voluntary registration of API commenced in April 2011, started with New Drug Products (NDP), followed
by mandatory registration of API for NDP which were implemented in January 2012. As for Generics, the
mandatory registration of API will be announced at a later date.
OTC ­ ABRIDGED VS OTC FULL EVALUATION

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GENERIC PHARMACEUTICAL 
PRODUCT

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 OTC Products

All products other than the  1. Antiseptics/ skin disinfectants 
listed categories under  2. Locally­acting lozenges/ pastilles
Abridged Evaluation 3. Topical analgesic/ counter­irritants
4. Topical nasal decongestants
5. Emollient/ demulcent/ skin 
protectants
6. Keratolytics
7. Anti­dandruff
8. Oral care
9. Anti­acne
10. Medicated plasters/ patch/ pad 
11. Topical antibacterial

* Generally dosage forms other  * Generally external (skin) and locally­acting 
than external (skin) and locally­ dosage forms eg. creams, ointments, 9
acting dosage forms eg. oral ,  lozenges, pastilles (relatively lower risk 
parenteral, rectal, vaginal, ocular,  compared to OTC Full Evaluation)
otic etc.
 ABRIDGED EVALUATION FOR OTC PRODUCTS

1. Antiseptics/ skin disinfectants; 
2. Locally­acting lozenges/ pastilles; 
3. Topical analgesic/ counter­irritants; 
4. Topical nasal decongestants; 
5. Emollient/ demulcent/ skin protectants; 
6. Keratolytics; 
7. Anti­dandruff; 
8. Oral care; 
9. Anti­acne; 
10. Medicated plasters/ patch/ pad; and 
11. Topical antibacterial. 

OTC Abridged Characteristic : External (skin) 
preparation and locally­ acting 
(lozenges/pastilles) dosage forms. 10
OTC ABRIDGE EVALUATION ­ 
EXAMPLES

11
No Category  Examples Active ingredient(s)
1. Antiseptics/ skin  Dettol Antiseptic  isopropyl alcohol, ethyl 
disinfectants  Liquid, Eusol  alcohol,  chlorhexidine, 
* For use on the  Solution povidone­iodine, acriflavine, 
human body chloroxylenol, cetrimide
2. Locally­acting  Sore throat/ cough  dequalinum, menthol, 
lozenges/  lozenge eg  amylmetacresol, 
pastilles  Strepsils,  dichlorobenzyl alcohol, 
Fisherman Friend hexylresorcinol
3. Topical  Cream/ointment  menthol, camphor, methyl 
analgesic/  /gel for muscle and  salicylate, capsaicin
counter­irritants  joint pain (muscle 
rub)
4. Topical nasal  Vicks Vaporub menthol, camphor, 
decongestants  eucalyptus oil
5. Emollient/  Aqueous cream,  calamine +/­ zinc oxide
demulcent/ skin  Calamine lotion
protectants 12
No Category  Examples Active ingredient(s)
7 Anti­dandruff tar, selenium sulfide
8 Oral care Antiseptic  povidone­iodine, thymol, 
mouthwash/gargles chlorhexidine, hexetidine, 
cetylpiridinium
9 Anti­acne salicylic acid, triclosan, 
benzoyl peroxide, 
resorcinol
10 Medicated  menthol, camphor, methyl 
plasters/ patch/  salicylate, glycol 
pad salicylate, povidone­
iodine, acriflavine
11 Topical  antiseptics, anti­acne
antibacterial

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OTC FULL EVALUATION ­ 
EXAMPLES

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No Category Examples Active 
ingredient(s)
1. Anti­haemorrhoids Diosmin,  Benzyl benzoate/peru 
Hesperidin balsam/zinc oxide
2. Anti­scabies/lice benzyl benzoate, 
crotamiton, 
permethrin, 
malathion
3. Antidotes/overdosage  acetylcysteine, 
treatment calcium folinate, 
protamine,  charcoal, 
phytomenadione, 
deferoxamine, 
pralidoxime, 
disodium edetate
4. Antacids  & antiflatulent  Gaviscon Liquid simethicone, 
polydimethylsiloxane 
(PDMS), activated 
charcoal
5. Antihelmintics  albendazole, 
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mebendazole
No Category Examples Active ingredient(s)
6. Contrast media for  Gadovist gadolinium based (gadobutrol, 
Magnetic Resonance  gadobenate, gadodiamide, 
Imaging (MRI) Iodinated
7. Diluents/solvent/vehicle/ca water for injection, glucose, 
rrier solution for  sodium chloride infusion solution
compatible electrolyte 
concentrates and 
medications 
8. Enzymes & bile salts lysozyme, papain, fungal 
diastase, pancreatin 
9. Expectorant guaiphenesin, ipecahuanha, 
ammonium chloride
10. Haematinics Cosmofer  iron salts (eg. ferrous fumarate , 
injection ferric sodium citrate, iron 
dextran/iron sucrose/iron 
polymaltose complexes), vitamin 
B substances
11. Laxatives Fleet,  Bisacodyl, lactulose, psyllium , 
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Picoprep liquid paraffin, 
No Category Examples Active ingredient(s)

13. Non­radioactive diagnostic  fluorescein sodium

preparations 

14. Non­opiod analgesics  Panadol paracetamol  +/­ caffeine, aspirin

15. Oral Rehydration Salts  diosmectite, kaolin/pectin/kaolin­

(ORS) & antidiarrhoeals  pectin

16. Osteoarthritis adjuvant  glucosamine, +/­ chondroitin, 

therapy methylsulfonylmethane (MSM)
17. Phosphate binders  calcium carbonate/acetate, 
aluminium hydroxide

18. Potassium binder sodium/calcium polystyrene 

sulphonate

19. Total Parenteral Nutrition  Amino acids

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* excluding tryptophan
(TPN)
No Category Examples Active ingredient(s)
20. Topical anti­ tar, polytar, zinc oxide
psoriasis/eczema 
21. Topical antifungals  clotrimazole, terbinafine, 
tolnaftate, amorolfine, ciclopirox, 
benzoic acid/salicylic acid/sulfur, 
zinc undecenoate,  naftifine 
hydrochloride 
22. Vitamin B substances for  Neurobion Mecobalamin, thiamine, 
neurological/nerve  cyanocobalamine, pyridoxine, B 
disorders & anaemia  complex
23. Vitamin D (cholecalciferol)  Vitamin D analogues ­ 
and its analogues alfacalcidol, calcitriol

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FEES, TIMELINE, REGISTRATION 
PROCESS & REQUIREMENTS

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 PROCESSING FEES

Product Processing
No Analysis Fees (RM) Total Fees (RM)
Categories Fees (RM)

Single active ingredient : 4,000.00

Pharmaceutical 3,000.00
(New Drug
1 1,000.00
Products &
Two or more active
Biologics)
ingredients : 4,000.00 5,000.00

Single active ingredient : 2,200.00

Pharmaceutical 1,200.00
(Generics and
2 1,000.00
Health
Two or more active
Supplements)
ingredients: 2,000.00 3,000.00

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Natural
3 500.00 700.00 1,200.00
Products
TIMELINE
No. Product Category
* Duration
(Inclusive screening
(A) Full Evaluation process)

1. New Drug Products 245 working days

2. Biologics 245 working days

3. Generics (Scheduled Poison) 210 working days

4. Generics (Non-Scheduled Poison) 210 working days

* Upon receipt of complete  21
application.
No. Product Category
*Duration
(Inclusive screening
(B) Abridged Evaluation
process)

Generics (Non-Scheduled Poison/OTC)

a) 116 working days
5. a) Single active ingredient
b) 136 working days
b) Two (2) or more active ingredients
Natural Products
6. a) Single active ingredient a) 116 working days
b) Two (2) or more active ingredients b) 136 working days
7. Health Supplements a) 116 working days
a) ** Single active ingredient b) 136 working days
b) ** Two (2) or more active ingredients
** Applicable for:
i) General or Nutritional Claims; and c) 245 working days
ii) Functional Claims (Medium Claims)
c) Disease Risk Reduction Claims
(High Claims)
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* Upon receipt of complete application.
 Overview of Product Registration 
Process
Pre-Submission of Registration
Application

* GMP Inspection

Submission of Registration
Application and Screening Process

Data Evaluation ** Sample testing

Meeting of the Drug Evaluation Committee (twice monthly)

Meeting of the Authority (monthly)

Assigning a registration number

Approval Rejection Appeal
(MAL no.) & Issuance of certificate
Regulation 18, CDCR 1984
*     Good Manufacturing Practice (GMP) 
*** Licensing Post-Registration Process
Certification
**    For natural products only  23
Surveillance & Pharmacovigilance ***   Application for Import and/or Wholesale 
or License 
Amendments/Variations
       ORGANIZATION OF APPLICATION DOSSIER

Country­specific
 administrative data.
Not part of ACTD Part I
Table of
 Contents,
Common 
Administrative Data
& Product Information
ACTD
  Part IV    
     Part II   Part III   Clinical
     Quality    Non­clinical
  Overview,
 Overall Summary
Overview, 
  Summary, 
& Reports       Summary
  Assessment 
& Study Reports*
Reports, 
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  & Study Reports*
* Upon Request
 ABRIDGED EVALUATION VS FULL EVALUATION

1. Timeline for OTC Abridge Evaluation (116­136 working 
days) is faster compared to Full Evaluation (210 
working days)
2. OTC Abridged Evaluation does not required complete 
Part I & II documentation like Full Evaluation. 
3. These following major documents are exempted for OTC 
abridged evaluation :
(i) Part I, Product Information ­ 
pharmacodynamics, pharmacokinetics and 
pregnancy & lactation information 
(ii) Part II ­ BA/BE Study Report, Process Validation 
Report & Analytical Validation Report  
* bypass Centre for Quality Control pre­registration  25

documentation evaluation
 HOW WE EVALUATE?
1. Relevant Acts & Regulations (Poison Act, CDCR etc) 
2. DCA Policies/Circulars/Directives, Meeting Minutes (JKPP, 
DCA, policy, JKPPP), GMP Status List (updated monthly)
3. Guidelines (DRGD,  ACTD/ASEAN /  WHO / EMA / 
USFDA/Health Canada) 
4. Standard References ((Martindale,  Micromedex, 
Pharmacopeia [BP,EP USP], Innovator’s PI & CoA, Approved PI 
& SmPC from Reference countries eg UK EMC)
5. Pharmasearch Database (Search by product name, API 
substance, dosage form, manufacturer)
6. Evaluator’s Checklist/Manual,  NPCB PI template

For OTC Products, we also use USFDA Federal Register 
& Health Canada Monograph as references 27
ISSUES & CHALLENGES

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OTC ABRIDGED EVALUATION – 
ISSUES & CHALLENGES
 OTC Classification is heavily tied up to Poison Act 1952  
reclassification from poison to non­poison (OTC) drug 
authorised by Poison Board
 The registration process is not really ‘simplified’, only some 
major requirements are not required and the timeline is faster
 ‘Grey area’/interphase products eg.:
~ Pharmaceutical/TMHS Interphase
~ Medical Device/ Drug Interphase
~ Cosmetic/Drug Interphase
 New Drug Products (NDP) containing Non­Scheduled Poisons 
 eg. New form/salt, new dosage form, new route of administration, 
new combination of active ingredients, new indications/ dosage etc.

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30