Ministry Of Health. Member of Pharmaceutical Inspection Cooperation Scheme. WHO Collaborating Centre For Regulatory Control of Pharmaceuticals

Transcription

1 Ministry Of Health MS ISO 9001:2008 Certified Member of Pharmaceutical Inspection Cooperation Scheme WHO Collaborating Centre For Regulatory Control of Pharmaceuticals National Pharmaceutical Control Bureau Ministry Of Health Malaysia Lot 36, Jalan Universiti Petaling Jaya MALAYSIA Tel : Fax : Website : 1

2 CONTENTS Introduction Legislation Overview of Regulatory Control Categories of Product Application Formalities How To Apply and Fees Process of Product Registration Data Requirements Maintenance of Registration Overview of Product Registration 2

3 Pharmaceutical Services Of Malaysia DIRECTOR Pharmaceutical Programme DIRECTOR (Pharmaceutical Care Management) DIRECTOR (Licensing & Enforcement) DIRECTOR OF NPCB (Quality Assurance of Pharmaceuticals) Objective: To ensure that therapeutic substances approved for the local market are and of NATIONAL PHARMACEUTICAL CONTROL BUREAU MINISTRY OF HEALTH MALAYSIA 2

4 LEGISLATIONS Other legislations that allow controls and regulations on pharmaceutical sector, include but not limited to the following: 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

5 LEGISLATIONS Control of Drugs and Cosmetics Regulations (CDCR) 1984 Regulation 7(1) No person shall manufacture, sell, supply, import, possess or administer any product unless: (a) the product is a registered product, and (b) the person holds the appropriate license required & issued under these Regulations. Overview of Product Registration 5

6 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 and to sell by wholesale or supply the products; a wholesaler's licence, authorising the licensee to sell by wholesale or supply the registered products from the address of the business premises specified in the licence; an import licence, authorising the licensee to import and sell by wholesale or supply the registered products from the address of the premises specified in the licence. - therefore, imported product such as from Japan can be imported into Malaysia by an importer who holds the import license. Overview of Product Registration 6

7 Overview of Regulatory Control Regulatory Components Registration Licensing Pharmacovigila nce Analysis Surveillance National Pharmaceutical Control Bureau MOH Malaysia 7

8 NEW PRODUCTS Registration Phases Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 BIOTECHNOLOGY Registration Aug 1985 (Prescription Drugs) Registration 1988 (OTC) Registration Jan 1992 (Traditional Medicine) Registration Feb 2002 (Cosmetics) Registration Aug 2007 (Veterinary) Regulatory control of Active Pharmaceutic al Ingredient (API)** VETERINARY MEDICINE Licensing May 1987 Licensing 1992 Licensing Manufacturer Importers Jan 1999 Licensing Jan 2004 Licensing 1 July 2012* No licensing Requirements as registration of API is linked to products ACTIVE PHARMACEUTICAL INGREDIENTS Surveillance Surveillance Surveillance 1995 Licensing Wholesalers July 2002 Surveillance 2000 Surveillance 2005 Surveillance Surveillance (to (to be be announced) announced) Surveillance (to be announced) 1 st 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, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 1 Tahun 2012 ** 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 As for Generics, the mandatory registration of API will be announced at a later date. Overview of Product Registration 8

9 Functions of Center for Product Registration 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) Overview of Product Registration 9

10 DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) DRGD serves as a reference guide for both pharmaceutical products for human use and natural products. (List of Prohibited & Restricted Ingredient Appendix 8) A separate guideline is available for Cosmetic Notification and registration of Veterinary products. Overview of Product Registration 10

11 Application Formalities The applicant for product registration (Product Registration Holder, PRH) must be a locally incorporated company, corporate or legal entity in the field of pharmaceuticals, with permanent address and registered with Companies Commissioner of Malaysia with the scope of business related to the health/ pharmaceutical product. Overview of Product Registration 11

12 Responsibility of Product Registration Holder Responsible for all information pertaining to quality, safety and efficacy in support of the product registration application; and shall inform the Authority in a timely manner any change in product information during course of evaluation. Under the CDCR 1984, Regulation 8(9): Any person who knowingly supplies any false or misleading information to the Authority with his application for the registration of a product commits an offence. Overview of Product Registration 12

13 Responsibility of Product 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) compliance of the manufacturers (and repackers, where applicable). - Under the CDCR 1984, Regulation 8(5): Any change in any document, item, sample, particulars or information which shall be notified in writing by the applicant to the Authority within fourteen (14) days from the date of such change. - Any decision to withdraw the registration of the product with reasons. Overview of Product Registration 13

14 Responsibility of Product Registration Holder To notify the Authority of any change in correspondence details, including the name, address, contact person, telephone number, fax number and ; To notify the Authority immediately upon cessation of the applicant as the product registration holder; Overview of Product Registration 14

15 HOW TO APPLY & FEES Overview of Product Registration 15

16 Application Procedure Registration of products shall be done via a web-based QUEST online system at Applicant must first register a membership for QUEST system with NPCB and purchase a USB Token that contains a User Digital Certificate from Digicert Sdn. Bhd. NPCB reserves the rights to approve or reject any application for the QUEST membership. Overview of Product Registration 16

17 Overview of Product Registration 17

18 Overview of Product Registration 18

19 Overview of Product Registration 19

20 Fees (effective as of January 2007) No Product Categories Processing Fees (RM) Analysis Fees (RM) Total Fees (RM) 1 Pharmaceutical (New Drug Products & Biologics) 1, Single active ingredient : 3, Two or more active ingredients : 4, , , Pharmaceutical (Generics and Health Supplements) Natural Products 1, Single active ingredient : 1, Two or more active ingredients: 2, , , , The processing fee is NOT REFUNDABLE [CDCR Reg. 8(4)] 20

21 FEES FOR VETERINARY PRODUCTS Processing 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 Overview of Product Registration 21

22 Organization of Application Dossier Country-specific administrative data. Not part of ACTD Part I Table of Contents, Common Administrative Data & Product Information ACTD Part II (Quality) Overall Summary & Reports Part III Non-clinical (Safety) Overview, Summary & Study Reports* Part IV Clinical ( Efficacy) Overview, Summary, Assessment Reports, & Study Reports* * Upon Request 22

23 Overview of Product Registration Process Pre-Submission of Registration Application Submission of Registration Application and Screening Process * GMP Inspection Data Evaluation ** Sample testing Meeting of the Drug Evaluation Committee (twice monthly) Meeting of the Drug Control Authority (monthly) Approval Assigning a registration number (MAL no.) & Issuance of certificate Rejection Appeal Regulation 18, CDCR 1984 *** Licensing Post-Registration Surveillance & Pharmacovigilance, Amendments/Variation * Good Manufacturing Practice (GMP) Certification ** For natural products only *** Application for Import and/or Wholesale License 23

24 Registration Criteria (Quality, Safety, Efficacy) Product Name Product Description Pack size Type of container Compulsory labeling requirement Additional Warning/ Precaution Products Particulars Labeling Requirement Manufacturer - GMP - CPP - CFS Product Formulation Interchangeability Banned ingredient Limits Product testing FPQC, Stability Bioequivalence/ Bioavailability Studies 24

25 REGISTRATION PROCESS Evaluation of application dossier Verification of GMP status (approval from recognized authority of the country of origin), CPP and CFS Protocol Evaluation and Testing NCE/Biotechnology send to panel of experts for comments Product Evaluation Committee (within NPCB) Applicant can appeal through Minister of Health for review of DCA s decision Drug Control Authority (decision making body meets monthly) Application rejected Registered 25

26 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 application. Overview of Product Registration 26

27 Timeline No. Product Category *Duration (Inclusive screening (B) Abridged Evaluation process) Generics (Non-Scheduled Poison) (Product categories as stated in Table V above) Natural Products a) Single active ingredient b) Two (2) or more active ingredients Health Supplements a) ** Single active ingredient b) ** Two (2) or more active ingredients ** Applicable for: i) General or Nutritional Claims; and ii) Functional Claims (Medium Claims) 80 working days a) 116 working days b) 136 working days a) 116 working days b) 136 working days c) 245 working days c) Disease Risk Reduction Claims (High Claims) * Upon receipt of complete application. 27

28 bpfk.gov.my 28

29 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, colonystimulating factors, tumour necrosis factors. Cell and tissue-based therapy products Gene therapy products Overview of Product Registration 29