Podcast
Questions and Answers
What is the primary aim of regulatory control in the context of pharmaceutical products?
What is the primary aim of regulatory control in the context of pharmaceutical products?
Which of the following is NOT one of the regulatory components mentioned?
Which of the following is NOT one of the regulatory components mentioned?
Which section of the Drug Registration Guidance Document focuses on the procedures following registration?
Which section of the Drug Registration Guidance Document focuses on the procedures following registration?
In the classification of new drug products, what is a New Chemical Entity (NCE)?
In the classification of new drug products, what is a New Chemical Entity (NCE)?
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What is one expectation patients have regarding new medical innovations?
What is one expectation patients have regarding new medical innovations?
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Which of the following options correctly describes biologics?
Which of the following options correctly describes biologics?
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Which of the following is NOT categorized as a generic application in Malaysia?
Which of the following is NOT categorized as a generic application in Malaysia?
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What is a defining characteristic of health supplements?
What is a defining characteristic of health supplements?
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Which of the following products is considered a biologic?
Which of the following products is considered a biologic?
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Which statement about health supplements is true?
Which statement about health supplements is true?
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Study Notes
Regulatory Pharmacist Roles
- Regulatory pharmacists ensure drugs and medical products meet regulations before market release.
- They work in both public and private sectors.
Regulatory Aim
- To ensure that approved therapeutic substances for local markets are safe, efficacious, and of good quality.
- To ensure that cosmetic products approved are safe and of good quality.
Patient, Prescriber, and Industry Perspectives
- Patients: Expect new medical treatments and timely access to new drugs.
- Prescribers: Want drugs reviewed and approved judiciously, and to be high quality, efficacious, and safe.
- Industry: Seek reduction in bureaucratic procedures and harmonization of standards and technical requirements.
Regulatory Control Components
- Registration includes licensing (manufacturer, import, and wholesaler).
- Analysis and education are key to regulation
- Pharmacovigilance and surveillance help control product safety and efficacy.
Drug Registration Guidance Document (DRGD)
- This document serves as a reference for medicinal product registration processes.
- It includes quality control, inspection, licensing, and post-registration activities.
- The document has five sections covering general overview, registration process, quality control, inspections/licensing/certification and post-registration process.
Categories of Medicinal Products
- New drug products
- Biologics
- Generics
- Health supplements
- Natural products
New Drug Products (NDPs)
- Any pharmaceutical product not previously registered.
- Classified as New Chemical Entities (NCEs), defined as active moieties/radiopharmaceuticals not registered as pharmaceutical products, or as Hybrids (single/combination products with existing active moieties).
Biologics
- Products whose active substances are created by, or derived from living organisms (plant, human, animal, or microorganisms).
- Can be produced using biotechnology methods.
- Include a wide range of products like vaccines, blood products, monoclonal antibodies, recombinant proteins (e.g., insulins, hormones, erythropoetins), and Cell and Gene Therapy Products (CGTPs).
Generics
- Products essentially similar to registered products in Malaysia.
- Excludes biologics.
- Includes Scheduled Poisons (controlled medicine) with active ingredients listed in the Poisons Act 1952, and Non-Scheduled Poisons/Over-the-counter (OTC) products omitting those listed in the First Schedule of the Poisons Act 1952, but including any health supplements or natural products/cosmetics.
Health Supplements
- Supplements use in maintaining and enhancing human health.
- Presented in small dosages (capsules, tablets, powder, liquid).
- Do not include sterile preparations (like injectable).
- Can contain various elements (vitamins, minerals, amino acids, etc., and their combinations) or naturally derived extracts and isolates.
- synthetic sources must have proven safety.
Natural Products
- Medicines, herbal products, homeopathic medicines, and natural products with therapeutic claims.
- Exclude sterile preparations, vaccines, substance derived from human parts, or isolated/characterized chemical substance.
Overview of Product Registration Process
- The process involves pre-submission of an application, submission of an application and screening the process, data evaluation, meeting of the drug evaluation committee, approval, and also the post-registration process.
Cosmetics and Veterinary Products
- Separate guidelines for cosmetics (revision 2017) and veterinary products (REGOVP - version 2014) are available.
Workflow of a Notification Process for Cosmetic Products
- Cosmetic Notification Holders (CNHs) register via a portal.
- Form completion and payment are required.
- Compliance screening is conducted.
- Successful products are approved and will be issued with a notification note.
Regulation of Veterinary Products in Malaysia
- Products may be either Scheduled Poisons (as in the Poisons Act 1952) or Non-Scheduled Poisons/Over-the-counter (OTC).
- These may also include pesticides for internal and external use, animal feeds, or feed additives, and pesticides for external use.
- Involved authorities include the BPFK, and the Department of Veterinary Services (DVS) and the Pesticide Board.
Product Registration - Quality
- GMP inspection ensures basic GMP requirements (premises, facilities, equipment).
- Testing procedures and standard operating procedures, product security.
- Self-inspections and testing of products (compendial/noncompendial) including heavy metals (lead, mercury, arsenic) and microbial limit tests.
Product Registration - Safety
- Preclinical data, (animal studies/toxicology studies) required.
- Clinical safety data and ADR reports.
- Non-permitted ingredients must not be used (e.g., phenylpropanolamine, penicillin, tartrazine).
- Monitoring of heavy metals is included in the screening of traditional products.
- Product information including labeling about warning, precautions and any drug interactions.
Product Registration - Efficacy
- Clinical data on the product's efficacy
- Phase 2 and Phase 3 clinical trials, and Bioequivalence studies are required for product approval.
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Description
This quiz covers the essential roles of regulatory pharmacists in ensuring drug safety, efficacy, and quality. It discusses patient, prescriber, and industry perspectives, and the components of regulatory control including registration and pharmacovigilance. Test your knowledge on the critical aspects of pharmaceutical regulation.
