ROLES REGULATION OF PHARMACISTS

• Regulatory pharmacists ensure drugs and medical products meet regulations before they are available to customers and patients
• Regulatory Pharmacists can be in the public or private sector

Regulatory Aim

• Goal is to ensure therapeutic and cosmetic substances approved for the local market are safe, efficacious, and of good quality

What do they want?

• Patients expect treatment using new medical innovations and timely access to new drugs
• Prescribers expect drugs to be reviewed and approved judiciously and to be of quality, efficacious, and safe
• Industry wants reduction in bureaucratic procedures and harmonization of standards and technical requirements

Regulatory Control

• Regulatory control contains 6 regulatory components:
• Registration involves product classification guidelines, vaccines/blood product
• Licensing manages the manufacturer's, import, and wholesaler's license
• Analysis includes BE analysis which has efficacy
• Education offers general education
• Pharmacovigilance is the branch of pharmacy that deals with the adverse effects of drugs
• Surveillance does random sampling and post-marketing

Drug Registration Guidance Document (DRGD)

• The DRGD serves as the reference guide for medicinal products registration, not veterinary/cosmetic products
• DRGD includes quality control, inspection & licensing, and post registration activities
• The DRGD contains 5 main sections: General overview, product registration process, quality control, inspections/licensing/certificate, and post-registration process

Categories of Medicinal Products

• Product categories: new drug products, biologics, generics, health supplements, and natural products

New Drug Products

• Pharmaceutical products that have not been previously registered in accordance with the provisions of the CDCR 1984, which controls drug and cosmetic regulation
• NDP may be classified as new chemical entity, single/combination products with an active or hybrid substance never registered by the DCA

Biologics

• Products with active substances made by or derived from a living organism (plant, human, animal, or microorganism
• Biologics imitate natural biological substances such as hormones, enzymes, or antibodies produced by biotechnology methods and cutting-edge tech
• Includes vaccines, recombinant proteins, blood products, monoclonal antibodies, cell and gene therapy products (CGTPs)

Generics

• Products essentially similar to a currently registered product in Malaysia but does not apply to Biologics
• Includes scheduled poison, controlled medicine/control poison
• Non-scheduled poison has active ingredients

Health Supplements

• Any product used to supplement a diet and to maintain, enhance, and improve the health function of the human body, presented in small unit dosage forms
• Includes capsules, tablets, powder, or liquids
• They do not include any sterile preparations
• May contain vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances
• Includes substances derived from "natural sources" and synthetic ingredients

Natural products

• Include traditional and homeopathic medicines, herbal products, and natural products with therapeutic claims
• It does not include any sterile preparation, vaccine, or substance derived from human parts or isolated/characterized chemical substances

Overview of Product Registration Process

• The product registration starts with pre-submission of application, and then submission of registration application and screening process which leads to Data evaluation
• There is then a meeting of the drug evaluation committee, followed by a meeting of the authority
• If approval, there is licensing and a post registration process
• If rejection, there is appeal
• Good Manufacturing Practice (GMP) Certification is needed
• Applications for Manufacturer's, Import and/or Wholesaler's Licenses

Cosmetics and Veterinary Products

• Guidelines are available for cosmetics and veterinary products
• Guidelines for Control of Cosmetic Products in Malaysia (1st revision 2017) and Registration Guideline of Veterinary Products (REGOVP) (3rd version 2014)
• Workflow of the notification process for cosmetic products begins by a cosmetic notification holder completing a notification form and payment
• Includes compliance screening manufacture/import/market cosmetic product, if fails then rejection of notification

Regulation of Veterinary Products in Malaysia

• For veterinary products, the products containing scheduled poison are classified under the schedule of poison act
• Products containing animal feed and feed additives
• Consists of pesticides as listed under the First Schedule of Pesticide Act

Product Registration: Quality

• Requires a Certificate of Pharmaceutical Product: GMP Certificate & Certificate of Free Sale
• Requires GMP inspection which contains Basic GMP Requirements
• Requires premise and facilities, equipment, quality control, standard operating/testing procedures and products security
• Requires product testing with product specifications

Product Registration: Safety

• Requires Preclinical data/Animal studies and toxicology studies, and clinical safety data, including SAE & ADR reporting ADR monitoring
• Non-Permitted Ingredients include Phenylpropanolamine, penicillin for topical use, tartrazine, cyclamate, and Magnolia Officinalis
• Requires Screening of heavy metals in Traditional Products and product information and warning labels

Product Registration: Efficacy

• Requires clinical efficacy data with clinical trials of Phase 2 and 3 consisting of bioequivalence studies
• Clinical trials are investigation in human subjects intended to discover or verify the effects of an investigational
• Generally, clinical trials are categorised in 4 phases
• Phase 2 and Phase 3 are critical trials in humans

Bioequivalence studies

• Demonstrates equivalence biopharmaceutics quality between the generic medicinal product and a comparator medicinal product
• Allows bridging of preclinical tests and of clinical trials associated with the comparator medicinal product
• Considers that all generics should be the same active substances, unless properties differ significantly
• Generic medicinal product must have demonstrated the same qualitative and quantitative composition in active substances and the same dosage form as the medicinal product