The Roles of Regulatory Pharmacist PDF

THE ROLES OF REGULATORY PHARMACIST DR TUAN MAZLELAA TUAN MAHMOOD FACULTY OF PHARMACY UKM REGULATORY PHARMACIST? Help to ensure that drugs and medical products meet certain regulations before they can be on the market for customers/patients Can be in public/private sector REGULATORY AIM...

THE ROLES OF REGULATORY PHARMACIST DR TUAN MAZLELAA TUAN MAHMOOD FACULTY OF PHARMACY UKM REGULATORY PHARMACIST? Help to ensure that drugs and medical products meet certain regulations before they can be on the market for customers/patients Can be in public/private sector REGULATORY AIM To ensure that therapeutic substances approved for the local market are: Safe Efficacious Of good quality To ensure that cosmetic products approved are: Safe Of good quality WHAT DO THEY WANT? The perspectives of patients: Expect treatment using new medical innovations Timely access to new drugs The perspectives of prescribers: Expect drugs to be reviewed and approved in a judicious manner Expect drugs to be of quality, efficacious, safe The perspectives of industry: Reduction in bureaucratic procedures Harmonisation of standards and technical requirements REGULATORY CONTROL 6 regulatory components: Registration Licensing – manufacturer’s license, import license, wholesaler’s license Analysis Education Pharmacovigilance Surveillance DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) Serve as the reference guide for the registration process of medicinal products. Includes quality control, inspection & licensing and post registration activities of medicinal products Contains 5 main sections: Section A: General overview Section B: Product registration process Section C: Quality control Section D: Inspections, licensing, certificate Section E: Post-registration process CATEGORIES OF MEDICINAL PRODUCTS New drug products Biologics Generics Health supplements Natural products NEW DRUG PRODUCTS Any pharmaceutical products that have not been previously registered in accordance with the provisions of the CDCR 1984. NDP may be classified as: New Chemical Entity (NCE) (single/ combination products with an active substance never registered by DCA) Defined as an active moiety/ radiopharmaceutical substance that has not been registered in any pharmaceutical product. Hybrid (single/ combination products with registered active moieties) E.g. Registered chemical entity(s) in a new chemical form(s), Registered chemical entity(s) in a new dosage form(s), registered chemical entity(s) in a new dosage strength(s) with a change in dosing/ posology etc BIOLOGICS Refers to a product whose active substance is made by or derived from a living organism (plant, human, animal or microorganism) and may be produced by biotechnology methods and other cutting-edge technologies This product imitates natural biological substances in our bodies such as hormones, enzymes or antibodies. Include a wide range of products such as: Vaccines; Blood products; Monoclonal antibodies (therapeutics); Recombinant proteins: Insulins Hormones Erythropoetins and other hematopoietic factors Cytokines: interferons, interleukins, colony-stimulating factors, tumour necrosis factors Cell and Gene Therapy Products (CGTPs) GENERICS A product that is essentially similar to a currently registered product in Malaysia. However, the term generic is not applicable to Biologics. Categories of product that can be processed as generic application: Scheduled Poison (Known as Controlled Medicine/ Controlled Poison) Products containing active ingredients as listed in the First Schedule under Poisons Act 1952. Non-Scheduled Poison Products containing active ingredients which are not listed in the First Schedule under Poisons Act 1952; and are excluding active ingredients which are categorized under health supplements or natural products or cosmetics. HEALTH SUPPLEMENTS Refers to any product used to supplement a diet and to maintain, enhance and improve the health function of human body It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, liquids Shall not include any sterile preparations (i.e. injectable, eye drops) May contain one or more, or the following combinations: Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances; Substances derived from *natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite; Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven. NATURAL PRODUCTS Include traditional medicines, herbal products, homeopathic medicines and natural products with therapeutic claim. It shall not include any sterile preparation, vaccine, any substance derived human parts, any isolated and characterized chemical substances. OVERVIEW OF PRODUCT REGISTRATION PROCESS HOW ABOUT FOR COSMETICS AND VETERINARY PRODUCTS: Separate guidelines are available for cosmetics and veterinary products: Cosmetics: Guidelines for Control of Cosmetic Products in Malaysia – 1st revision 2017 Veterinary products: Registration Guideline of Veterinary Products (REGOVP) – 3rd version 2014 WORKFLOW OF A NOTIFICATION PROCESS FOR COSMETIC PRODUCTS REGULATION OF VETERINARY PRODUCTS IN MALAYSIA PRODUCT REGISTRATION - QUALITY Certificate of Pharmaceutical Product : GMP Certificate & Certificate of Free Sale GMP inspection : Basic GMP Requirement Premise, Location and facilities, equipment and quality control Testing procedures and Standard Operating Procedures Products security, manufacturing records and recall procedures Self Inspection Product Testing : Product Specifications: Compendial/Non-compendial Heavy metals : Pb, Hg, As Microbial Limit Test PRODUCT REGISTRATION - SAFETY Preclinical data : Animal studies/ Toxicology studies Clinical safety data : SAE & ADR reporting from Clinical Studies, Periodic Safety Update Report, ADR monitoring Non-Permitted Ingredients : Eg. Phenylpropanolamine (ppa), penicillin for topical use, tartrazine, cyclamate, Magnolia Officinalis Screening of heavy metals in Traditional Products Product Information : warning labels/precautions/drug interactions/adverse effects PRODUCT REGISTRATION - EFFICACY Clinical efficacy data Clinical trials Phase 2 and Phase 3 Bioequivalence studies THANK YOU