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1、 NATIONAL PHARMACEUTICAL CONTROL BUREAUMINISTRY OF HEALTH MALAYSIAPETALING JAYADRUG REGISTRATION GUIDANCE DOCUMENTPREAMBLEThis “DRUG REGISTRATION GUIDANCE DOCUMENT” will serve as the reference guide for both pharmaceutical products for human use and traditional products. It will replace the “Guideli
2、nes For Application For Registration of Pharmaceutical Products” Third Edition of October 1993, and “Garispanduan Permohonan Pendaftaran Keluaran Ubat Tradisional” Second Edition, December 1998.The contents of this version include: Updated information relating to administrative requirements and proc
3、edures. Information on Drug Control Authority (DCA) policies currently applicable. Guidelines on the on-line application process and requirements which will incorporate the ASEAN technical requirements and standards for pharmaceuticals (where applicable).An on-going review of policy matters will con
4、tinue, taking into account the global regulatory environment, to allow for timely and pertinent changes.Information relating to DCA policy decisions is current up to its 158th meeting on 27 April 2004. Please visit the National Pharmaceutical Control Bureau (NPCB) website at http:/www.bpfk.gov.my fo
5、r updates in regulatory information.April 2004CONTENTSSECTION 1GENERAL OVERVIEW OF THE DRUG REGISTRATION SYSTEMIN MALAYSIA (INCLUDING ADMINISTRATIVE PROCEDURES)1. INTRODUCTION2. DRUG REGISTRATION 3. PROCEDURE FOR PROCESSING NEW APPLICATIONS 3.1Application Type3.2Data Requirements4. APPLICATION FORMA
6、LITIES 4.1 Responsibility of Marketing Authorization Holder 4.2 Application Fee4.3 Letter of Authorization and Certification Which Must Accompany Applications4.4 Multiple Applications5. PROCESSING OF APPLICATIONS5.1 Initiation of Review5.2 Stop Clock 6. REGULATORY OUTCOME6.1 Decisions of the DCA6.2
7、Product Registration Number6.3 Certificate of Registration Reg. 8(8)6.4 Rejection, Cancellation, Suspension of Registration Regs. 11 & 17(1)6.5 Appeal Against DCA Decisions Reg. 186.6 Decision Of The Minister Reg. 187. MAINTENANCE OF REGISTRATION7.1Conditions For Registration Reg. 8(1) 7.2 Validity
8、Period Of Registration Reg. 8(5)8. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS 9. REPORTING PROBLEMS WITH REGISTERED PRODUCTS9.1 Adverse Drug Reactions9.2 Market Surveillance of registered products9.3 Product Complaints9.4 Product Recalls10.TERMINATION OF PRODUCT REGISTRATION BY MARKETING AUTHORIZA
9、TION HOLDER11.CHANGE IN MARKETING AUTHORIZATION HOLDER OF A REGISTERED PRODUCT(UNDER REVIEW)12CHANGE IN MANUFACTURING SITE13.OTHER INFORMATION13.1Criteria for registration 13.2 Variants for a Given Product13.3Patented Products (UNDER REVIEW)13.4Products for export only13.5Combination (Combo) Packs 1
10、3.6Use of HALAL logo13.7Bioequivalence13.8 New / additional indication 14.TYPES OF APPLICATIONS15. APPENDICESSECTION 2GUIDE ON HOW TO FILL THE ON-LINE APPLICATION FORMFOR A NEW PRODUCT REGISTRATIONSTEP 1: PRODUCT VALIDATION FORM1 PRODUCT NAME2 DOSAGE FORM3 ACTIVE SUBSTANCE4 EXCIPIENT5 ANY PORCINE MA
11、TERIALS6 MANUFACTURER7 PRODUCT CLASSIFICATIONSTEP 2 : NEW REGISTRATION APPLICATION FORM PART I ADMINISTRATIVE DATA AND PRODUCT INFORMATIONSECTION A : PRODUCT PARTICULARS Product Description Pharmacodynamics & Pharmacokinetics Indication / Usage Dose / Use Instruction Recommended Dose & Route of Admi
12、nistration Contraindication Warnings and Precaution Drug Interaction Side Effects / Adverse Reactions Pregnancy and Lactation Signs and Symptoms of Overdose and Treatment Storage Conditions Shelf Life Therapeutic Code (if any) SECTION B : PRODUCT FORMULA Batch Manufacturing Formula Manufacturing Pro
13、cess Attachment of In Process Quality Control Attachment of Finished Product Quality Specification Attachment of Stability DataSECTION C : PARTICULARS OF PACKINGSECTION D : LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER CARTON AND PROPOSED PACKAGE INSERTPART II QUALITY DOCUMENTATIONPART III NON-CLINI
14、CAL (SAFETY) DOCUMENTATIONPART IV CLINICAL (EFFICACY) DOCUMENTATIONANNEX A GUIDELINES FOR THE SUBMISSION OF PROTOCOL OF ANALYSIS1. General Requirement2. Specific Requirement GUIDELINE FOR SUBMISSION OF SAMPLES TO THE DRUG ANALYSIS DIVISION FOR LABORATORY TESTING1. Introduction2. Requirement 3. Appea
15、l for RetestingGUIDELINE FOR SUBMISSION OF ANALYTICAL METHOD VALIDATION DOCUMENTS1. Introduction2. Requirement PAGE6789910111112121414141515151616161617171717171818191919192020222222232323252525262628293030313232323234343435353536363636363737373838383839393939393940414444444545454549494950515151SECT
16、ION 1GENERAL OVERVIEW OF THE DRUG REGISTRATION SYSTEM IN MALAYSIA (INCLUDING ADMINISTRATIVE PROCEDURES)SECTION 18. INTRODUCTION8.1 The Control of Drugs and Cosmetics Regulations 1984 was gazetted in June 1984, with the establishment of the Drug Control Authority (DCA) as the licensing authority. The
17、 daily operations of drug and cosmetic registration, together with the attendant monitoring and surveillance activities have been delegated to the National Pharmaceutical Control Bureau (NPCB).8.2 The guidelines outlined in this document are primarily drawn up in accordance to the legal requirements
18、 of the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984. While every effort has been made to include the legal requirements of other related legislation, wherever possible, applicants are reminded that it is still their responsibility to ensure that their products duly
19、 comply with the requirements of these legislation, namely:-(i) Dangerous Drugs Act 1952;(ii) Poisons Act 1952;(iii) Medicine (Advertisement & Sale) Act 1956;(iv) Patent Act 1983; and also(v) Any other relevant Acts.8.3 Regulation 7(1)(a) of the Control of Drugs and Cosmetics (Amendment) Regulations
20、 2001 requires all products to be registered with the DCA prior to being manufactured, sold, supplied, imported or possessed for sale, unless the product is exempted under the specific provisions of the Regulations.A product as defined in the Regulations means a drug in a pharmaceutical dosage form
21、or a cosmetic, having a singular identity, composition, characteristics and origin.Any change to the above defined parameters may result in the need to apply for a new product registration or an application for approval of an amendment (variation) to the existing product registration.8.4 Applicants
22、are encouraged to be familiar with the contents of these guidelines and the governing legislation before they submit applications for drug registration. A SEPARATE GUIDELINE IS AVAILABLE FOR THE APPLICATION FOR REGISTRATION OF COSMETIC PRODUCTS.9. DRUG REGISTRATION 9.1 Any drug in a pharmaceutical d
23、osage form, intended to be used, or capable or purported or claimed to be capable of being used on humans or any animals, whether internally or externally, for a medicinal purpose is required to be registered with the DCA.A SEPARATE GUIDELINE FOR APPLICATION FOR THE REGISTRATION OF VETERINARY PRODUC
24、TS WILL BE AVAILABLE.Medicinal purpose means any of the following purposes:(i) alleviating, treating, curing or preventing a disease or a pathological condition, or symptoms of a disease;(ii) diagnosing a disease or ascertaining the existence, degree or extent of a physiological or pathological cond
25、ition;(iii) contraception;(iv) inducing anaesthesia;(v) maintaining, modifying, preventing, restoring or interfering with, the normal operation of a physiological function;(vi) controlling body weight;(vii) general maintenance or promotion of health or well-being.9.2 The Regulations do not apply to
26、the following products :-(i) diagnostic agents and test kits for laboratory use;Diagnostic agents/test kits for laboratory use must be labelled FOR LABORATORY USE ONLY. Products which are not labelled as such shall be deemed to be for human or animal use and need to be registered with the DCA.(ii) n
27、on-medicated medical and contraceptive devices;(iii) non-medicated bandages, surgical dressings, plaster, dental fillings;(iv) instruments, apparatus, syringes, needles, sutures, catheters;(v) Food - as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, s
28、old or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This inclu
29、des food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable under the Food Act and Regulations.9.3 Products which are not registered with the Drug Control Authority and are intended to be imported
30、 for the purpose of clinical trial shall have a Clinical Trial Import Licence (CTIL). Reg. 12(1)(c)A SEPARATE GUIDELINE FOR APPLICATION FOR CLINICAL TRIAL IMPORT LICENCE IS AVAILABLE.9.4 Products which are not registered with the Drug Control Authority and are intended to be manufactured locally for
31、 the purpose of clinical trial shall require Clinical Trial Exemption (CTX) from the DCA. Reg. 15(5).9.5 Any person who wishes to manufacture any product solely for the purpose of producing a sample for registration should apply for an exemption for manufacture of sample. (Applies to locally manufac
32、tured products only.) Reg. 15(5).10. PROCEDURE FOR PROCESSING NEW APPLICATIONS 3.1Application TypeAn application for a new product registration may be sub-divided into one of the following:(i)Application for an innovator product (NCE1 / Biotech) containing a new chemical entity or a biological entit
33、y; containing a new combination of existing chemical/biological entity(s); containing existing chemical or biological entity(s) in a new dosage form; containing existing chemical or biological entity(s) for use by a different route of administration; 1 has not been registered by the DCA (ii)Applicat
34、ion for a generic2 product (Scheduled Poisons & Non-Scheduled Poisons) 2 a generic product is a product that is essentially similar to a currently registered product in Malaysia. The term generic is not applicable to biological & biotech products (iii) Application for product registration via the ab
35、ridged procedure (for certain categories3 of OTC products and also for traditional medicines) 3 antiseptics/skin disinfectants; lozenges/pastilles; dietary supplements; antidandruff; topical analgesics/counter-irritants; emollients/demulcents/protectants; oral care; anti-acne; keratolytic; topical n
36、asal decongestants 3.2Data RequirementsThe data required to support an application is divided into:a) administrative data (Part I); b) data to support product quality (Part II); c) data to support product safety (Part III); and d) data to support product efficacy (Part IV).Data to be submitted will
37、be based on each application type as follows:Innovator product Parts I to IV (except for existing chemical or biological entity(s) in a new dosage form which will require only Parts I & II, together with pharmacokinetic data)Generic product Parts I & IIAbridged procedure Part I onlyApplicants are ad
38、vised to read the explanatory notes in Section 2 of this guidance document, and also the relevant ASEAN or ICH guidelines and checklists, for full information on product data requirement. In order to facilitate the evaluation process, applicants should conform to these guidelines. The DCA may in cer
39、tain cases request for supplementary information. The applicant should make available the requested information within the specified period. Failure to do so may result in the rejection of the application for product registration.11. APPLICATION FORMALITIES The DCA accepts only web-based on-line sub
40、missions via http:/www.bpfk.gov.my.The applicant for product registration must be a locally incorporated company with a permanent address. The applicant (if said company is not the product owner) should be authorized in writing by the product owner to be the holder of the product registration certif
41、icate and be responsible for all matters pertaining to the registration of the product.4.1 Responsibility of Marketing Authorization Holder (i.e. the applicant for product registration)4.1.1 The applicant shall be responsible for the product and all information supplied in support of his application
42、 for registration of the product. He shall be responsible for updating any information relevant to the product/application. The DCA should be informed in a timely manner any change in product information during the course of evaluation, and after product registration, especially if the information p
43、ertains to rejection/withdrawal, additional data on product efficacy and safety or current Good Manufacturing Practice (cGMP) compliance of the manufacturers (and repackers, if applicable).4.1.2 Any person who knowingly supplies any false or misleading information in connection with his application
44、for registration commits an offence under the Control of Drugs and Cosmetics Regulations 1984. Reg. 8(9)4.1.3 The marketing authorization holder must assume responsibility for the quality, safety and efficacy of his products.4.2. Application Fee4.2.1Processing feeEvery application for registration s
45、hall be accompanied with a processing fee. The amount of fees is as stipulated in The Control of Drugs and Cosmetics (Amendment) Regulations 2002.4.2.2 Other chargesThe DCA will charge any applicant such costs it may incur for thepurpose of carrying out laboratory investigation/testing relating to t
46、he registration of any product. Reg. 8(3)Any payment made is not refundable once an application has been submitted and payment confirmed. Applications without the correct fees will not be processed. Reg. 8(4)4.3 Letter of Authorization and Certification Which Must Accompany ApplicationsLetters of authorization and certifications should be valid and current at the time of submission. 4.3.1 All applications for registration must be ac
