National Pharmaceutical Control BureauMinistry Of Health MalaysiaLot 36, Jalan Universiti46200 Petaling JayaMALAYSIATel : 603-7883 5400 Fax : 603-7958 1312Website : www.bpfk.gov.my
Ministry Of Health
MS ISO 9001:2008 Certified
Member of PharmaceuticalInspection Cooperation
Scheme
WHO CollaboratingCentre
For Regulatory Control ofPharmaceuticals
1
CONTENTS
IntroductionLegislationOverview of Regulatory ControlCategories of ProductApplication FormalitiesHow To Apply and Fees Process of Product Registration Data Requirements Maintenance of Registration
2Overview of Product Registration
Pharmaceutical Services Of MalaysiaDIRECTOR
PharmaceuticalProgramme
DIRECTOR(Pharmaceutical
Care Management)
DIRECTOR(Licensing &Enforcement)
DIRECTOR OF NPCB(Quality Assuranceof Pharmaceuticals)
NATIONAL PHARMACEUTICAL CONTROL BUREAUMINISTRY OF HEALTH MALAYSIA
Objective:To ensure that therapeutic substances approved for the local
market areand of
2
LEGISLATIONS
Other legislations that allow controls and regulations onpharmaceutical sector, include but not limited to thefollowing:
Registration of Pharmacists Act 1951, revised 1989 Poisons Act 1952 (revised 1989) Sale of Drugs Act 1952 (revised 1989) Dangerous Drug Act 1952 (revised 1980) Medicines (Advertisement and Sale) Act 1956 (revised
1983) Patents Act 1983
LEGISLATIONSControl of Drugs and Cosmetics Regulations
(CDCR) 1984
Regulation 7(1)No person shall manufacture, sell, supply, import,
possess or administer any productunless:
(a) the product is a registered product,and
(b) the person holds the appropriate licenserequired & issued under these Regulations.
5Overview of Product Registration
Imported Product
Regulation 12 of CDCR 1984: Licenses a manufacturer's licence, authorising the licensee to manufacture
the registered products in the premises specified in the licence andto sell by wholesale or supply the products;
a wholesaler's licence, authorising the licensee to sell by wholesaleor supply the registered products from the address of the businesspremises specified in the licence;
an import licence, authorising the licensee to import and sell bywholesale or supply the registered products from the address of thepremises specified in the licence. - therefore, imported product suchas from Japan can be imported into Malaysia by an importer whoholds the import license.
Overview of Product Registration 6
Overview of Regulatory ControlRegulatory Components
Registration
Pharmacovigilance
SurveillanceAnalysis
Licensing
7National Pharmaceutical Control Bureau MOH Malaysia
Registration Phases
Overview of Product Registration8
1st January 2008 – Registration of Cosmetics replaced by NOTIFICATION
Surveillance1990
Surveillance1995
Surveillance(to be
announced)
* 1st July 2012:All manufacturers shall be certified for GMP as directed via Directive Arahan di Bawah Peraturan 29,Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 1 Tahun 2012
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
BIOTECHNOLOGY
VETERINARYMEDICINE
LicensingMay 1987LicensingMay 1987
NEW PRODUCTS
Registration1988(OTC)
Registration1988(OTC)
RegistrationJan 1992
(TraditionalMedicine)
RegistrationJan 1992
(TraditionalMedicine)
RegistrationFeb 2002
(Cosmetics)
RegistrationFeb 2002
(Cosmetics)
RegistrationAug 2007
(Veterinary)
RegistrationAug 2007
(Veterinary)
Licensing1992
Licensing1992
LicensingManufacturer
ImportersJan 1999
LicensingManufacturer
ImportersJan 1999
LicensingJan 2004LicensingJan 2004
Licensing1 July 2012*Licensing
1 July 2012*
LicensingWholesalers
July 2002Surveillance
2000
Surveillance2005
ACTIVEPHARMACEUTICAL
INGREDIENTS
Phase 6
No licensingRequirementsas registration
of API islinked toproducts
No licensingRequirementsas registration
of API islinked toproducts
Regulatorycontrol of
ActivePharmaceutical Ingredient
(API)**
Regulatorycontrol of
ActivePharmaceutical Ingredient
(API)**
Surveillance(to be
announced)
Surveillance(to be
announced)
** Voluntary registration of API commenced in April 2011, started with New Drug Products (NDP), followedby mandatory registration of API for NDP which were implemented in January 2012. As for Generics, themandatory registration of API will be announced at a later date.
** Voluntary registration of API commenced in April 2011, started with New Drug Products (NDP), followedby mandatory registration of API for NDP which were implemented in January 2012. As for Generics, themandatory registration of API will be announced at a later date.
Surveillance1995
Surveillance1990
RegistrationAug 1985
(PrescriptionDrugs)
RegistrationAug 1985
(PrescriptionDrugs)
Functions of Center for ProductRegistration
Overview of Product Registration 9
Evaluation of product dossiers. Manual & On-line registration (QUEST 2--> QUEST 3) Product Classification Issuance of Product Registration Certificate Additional Indication of New Chemical Entities (NCEs) &
Biotech Products Certificate of Pharmaceutical Product (CPP) , Certificate
of Free Sale (CFS)
DRGD serves as a referenceguide for both pharmaceuticalproducts for human use andnatural products.(List of Prohibited & RestrictedIngredient – Appendix 8)
A separate guideline is availablefor Cosmetic Notification andregistration of Veterinaryproducts.
10Overview of Product Registration
DRUG REGISTRATION GUIDANCEDOCUMENT (DRGD)
Application Formalities The applicant for product registration (Product
Registration Holder, PRH) must be a locallyincorporated company, corporate or legal entityin the field of pharmaceuticals, with permanentaddress and registered with CompaniesCommissioner of Malaysia with the scope ofbusiness related to the health/ pharmaceuticalproduct.
11Overview of Product Registration
Responsibility ofProduct Registration Holder Responsible for all information pertaining to quality,
safety and efficacy in support of the product registrationapplication; and shall inform the Authority in a timelymanner any change in product information during courseof evaluation. Under the CDCR 1984, Regulation 8(9): Any person who
knowingly supplies any false or misleading informationto the Authority with his application for the registration ofa product commits an offence.
12Overview of Product Registration
Responsibility ofProduct Registration Holder Responsible for all matters pertaining to quality, safety
and efficacy of the registered product, including:- Data updates on product quality, safety and efficacy or
current Good Manufacturing Practice (cGMP) complianceof the manufacturers (and repackers, where applicable).
- Under the CDCR 1984, Regulation 8(5): Any change inany document, item, sample, particulars or informationwhich shall be notified in writing by the applicant to theAuthority within fourteen (14) days from the date of suchchange.
- Any decision to withdraw the registration of the productwith reasons.
Overview of Product Registration 13
Responsibility ofProduct Registration Holder To notify the Authority of any change in correspondence
details, including the name, address, contact person,telephone number, fax number and email;
To notify the Authority immediately upon cessation of theapplicant as the product registration holder;
Overview of Product Registration 14
Application Procedure
Registration of products shall be done via a web-basedQUEST online system at http://www.bpfk.gov.my
Applicant must first register a membership for QUESTsystem with NPCB and purchase a USB Token thatcontains a User Digital Certificate from Digicert Sdn. Bhd.
NPCB reserves the rights to approve or reject anyapplication for the QUEST membership.
16Overview of Product Registration
Fees(effective as of January 2007)
No ProductCategories
ProcessingFees (RM) Analysis Fees (RM) Total Fees (RM)
1
Pharmaceutical(New DrugProducts &Biologics)
1,000.00
Single active ingredient :3,000.00
4,000.00
Two or more activeingredients : 4,000.00
5,000.00
2
Pharmaceutical(Generics and
HealthSupplements)
1,000.00
Single active ingredient :1,200.00
2,200.00
Two or more activeingredients: 2,000.00
3,000.00
3 NaturalProducts 500.00 700.00 1,200.00
The processing fee is NOT REFUNDABLE [CDCR Reg. 8(4)]20
FEES FOR VETERINARY PRODUCTSProcessing fee + analysis fee: For Scheduled Poison, Non-Scheduled Poison &
Health/ Dietary Supplement products : RM1,500 For Herbal/Natural products : RM1,200 For Export Only-Scheduled Poison : RM 500 For Export Only-Notification for Other than
Scheduled Poison : RM 100
21Overview of Product Registration
Organization of Application Dossier
* Upon Request
Part ITable of
Contents,Common
Administrative Data& Product Information
Part II(Quality)
Overall Summary& Reports
Part IIINon-clinical
(Safety)
Overview,Summary & Study
Reports*
Part IVClinical( Efficacy)Overview,Summary,Assessment Reports,& Study Reports*
Country-specificadministrative data.Not part of ACTD
ACTD
22
23
Overview of Product Registration ProcessPre-Submission of Registration
Application
Submission of RegistrationApplication and Screening
Process
Data Evaluation ** Sample testing** Sample testing
* GMP Inspection* GMP Inspection
Meeting of the Drug Evaluation Committee (twicemonthly)
Meeting of the Drug Control Authority(monthly)
*** Licensing*** Licensing
ApprovalApproval
Post-RegistrationPost-Registration
RejectionRejection AppealAppeal
* Good Manufacturing Practice (GMP) Certification** For natural products only*** Application for Import and/or Wholesale License
Regulation 18, CDCR 1984
Assigning a registration number(MAL no.) & Issuance of
certificate
Surveillance &Pharmacovigilance,
Amendments/Variation
Products Particulars ProductFormulation
LabelingRequirement
Interchangeability
Manufacturer- GMP- CPP- CFS
Registration Criteria(Quality, Safety, Efficacy)
CompulsorylabelingrequirementAdditionalWarning/Precaution
Product NameProductDescriptionPack sizeType of container
Bioequivalence/Bioavailability
Studies
BannedingredientLimitsProduct testingFPQC, Stability
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REGISTRATION PROCESS
Evaluation of application dossier
Product EvaluationCommittee (within NPCB)
Drug Control Authority(decision making body
– meets monthly)
Application rejected
Registered
Applicant can appeal through Minister ofHealth for review of DCA’s decision
Verification of GMP status (approval from recognizedauthority of the country of origin), CPP and CFSProtocol Evaluation and TestingNCE/Biotechnology – send to panel of experts for comments
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Timeline
26Overview of Product Registration
No. Product Category * Duration(Inclusive screening
process)(A) Full Evaluation
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 application.
Timeline
27
No. Product Category *Duration(Inclusive screening
process)(B) Abridged Evaluation
5.Generics (Non-Scheduled Poison)(Product categories as stated in Table V above)
80 working days
6.Natural Productsa) Single active ingredientb) Two (2) or more active ingredients
a) 116 working daysb) 136 working days
7.Health Supplementsa) ** Single active ingredientb) ** Two (2) or more active ingredients** Applicable for:i) General or Nutritional Claims; andii) Functional Claims (Medium Claims)
c) Disease Risk Reduction Claims(High Claims)
a) 116 working daysb) 136 working days
c) 245 working days
* Upon receipt of complete application.
Biologics include a wide range of products such as: Vaccines; Blood products; Monoclonal antibodies (therapeutics); Recombinant proteins: Hormones Erythropoetins and other hematopoietic factors Cytokines: Interferons, interleukins, colony-
stimulating factors, tumour necrosis factors. Cell and tissue-based therapy products Gene therapy products
29Overview of Product Registration
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