Podcast
Questions and Answers
Which of the following substances are excluded from the category of natural products?
Which of the following substances are excluded from the category of natural products?
What is a requirement for the quality registration of products?
What is a requirement for the quality registration of products?
Which of the following is considered a non-permitted ingredient in product registration?
Which of the following is considered a non-permitted ingredient in product registration?
What type of studies are necessary to demonstrate clinical efficacy during product registration?
What type of studies are necessary to demonstrate clinical efficacy during product registration?
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Which document is NOT part of the quality requirements for product registration?
Which document is NOT part of the quality requirements for product registration?
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What is the primary role of a regulatory pharmacist?
What is the primary role of a regulatory pharmacist?
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Which of the following is NOT a regulatory aim for therapeutic substances?
Which of the following is NOT a regulatory aim for therapeutic substances?
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Which regulatory component involves the monitoring of drug safety after it has been approved?
Which regulatory component involves the monitoring of drug safety after it has been approved?
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What is included in the Drug Registration Guidance Document?
What is included in the Drug Registration Guidance Document?
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Which category of medicinal products includes those with active substances that have never been registered before?
Which category of medicinal products includes those with active substances that have never been registered before?
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What do patients expect from regulatory pharmacists in terms of new medical innovations?
What do patients expect from regulatory pharmacists in terms of new medical innovations?
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What aspect of the registration process includes checks for product quality and safety?
What aspect of the registration process includes checks for product quality and safety?
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Which of the following describe the perspectives of industry regarding regulatory procedures?
Which of the following describe the perspectives of industry regarding regulatory procedures?
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Which of the following is NOT considered a biologic?
Which of the following is NOT considered a biologic?
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Which type of product can be processed as a generic application?
Which type of product can be processed as a generic application?
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What is the primary purpose of health supplements?
What is the primary purpose of health supplements?
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Which of these substances are typically included in health supplements?
Which of these substances are typically included in health supplements?
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What distinguishes biologics from other types of products?
What distinguishes biologics from other types of products?
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Which of the following is a characteristic of generics?
Which of the following is a characteristic of generics?
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Which of the following ingredients may be included in health supplements?
Which of the following ingredients may be included in health supplements?
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What is the regulation status of products containing active ingredients not listed under the Poisons Act?
What is the regulation status of products containing active ingredients not listed under the Poisons Act?
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Study Notes
Roles of Regulatory Pharmacist
- Regulatory pharmacists ensure drugs and medical products meet regulations before release.
- They can work in both public and private sectors.
Regulatory Aim
- Ensure therapeutic substances approved for the local market are safe, efficacious, and of good quality.
- Ensure cosmetic products approved are safe and of good quality.
What Patients and Prescribers Want
- Patients: Expect new medical innovations, timely access to new drugs.
- Prescribers: Drugs reviewed and approved judiciously, with quality, efficacy and safety.
- Industry: Reduced bureaucratic procedures, harmonized standards and technical requirements.
Regulatory Control Components
- Registration (manufacturer's, import, wholesaler's license).
- Analysis.
- Education.
- Pharmacovigilance.
- Surveillance.
Drug Registration Guidance Document (DRGD)
- Serves as a reference guide for registering medicinal products.
- Includes quality control, inspection, licensing, and post-registration activities.
- Composed of 5 sections:
- General overview.
- Product registration process.
- Quality control.
- Inspections, licensing, and certification.
- Post-registration process.
Categories of Medicinal Products
- New drug products.
- Biologics.
- Generics.
- Health supplements.
- Natural products.
New Drug Products
- Products that have not been previously registered (per CDCR 1984).
- Classified as:
- New Chemical Entity (NCE): single/combination products with an active substance never registered by DCA.
- Defined active moiety/radiopharmaceutical substance not previously registered.
- Hybrid single or combination products with active moieties already registered (e.g., new forms, dosage strengths, changed dosage/dosing).
Biologics
- Active substances derived from living organisms (plant, human, animal, microorganism), potentially using biotechnology and other advanced technologies.
- Mimic biological substances in the body (hormones, enzymes, antibodies).
- Includes a range of products like: vaccines, blood products, monoclonal antibodies (therapeutics), recombinant proteins (insulins, hormones), erythropoetins, cytokines (interferons, interleukins, colony-stimulating factors, tumour necrosis factors), and cell and gene therapy products.
Generics
- Products essentially similar to currently registered products in Malaysia.
- Biologics are excluded.
- Applicable to products with active ingredients listed in the First Schedule of the Poisons Act 1952.
- Excludes non-scheduled poisons and products categorized as health supplements, natural products, or cosmetics.
Health Supplements
- Products supplementing the health function of the body.
- Presented in various forms: capsules, tablets, powders, liquids.
- Not sterile preparations (e.g., injectable, eye drops).
- May combine vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances.
- Includes materials from natural sources (animal, mineral, botanical) and synthetic materials (when safety is proven).
Natural Products
- Includes traditional medicines, herbal products, homeopathic medicines, and natural products with therapeutic claims.
- Does not include sterile preparations, vaccines, substances derived from humans, or isolated, characterized chemical substances.
Overview of Product Registration Process
- A diagram showing the pre-submission, submission, evaluation, approval, rejection and appeal stages.
- Registration application and screening, data evaluation, meeting of the drug evaluation committee, and post-registration procedure are included.
Cosmetics and Veterinary Products
- Separate guidelines exist for cosmetics and veterinary products.
- Cosmetic guidelines (e.g., revision 2017).
- Veterinary Guidelines (e.g., registration guideline of veterinary products – version 2014).
Workflow of Notification Process for Cosmetic Products
- A flowchart illustrating the process for notification of cosmetic products.
Regulation of Veterinary Products in Malaysia
- Products regulated include scheduled poisons, non-scheduled poisons/over-the-counter products, pesticides for internal and external use, animal feed, feed additives, pesticides listed under the Pesticide Act,1974 for external use only.
Product Registration - Quality
- GMP Certificate and Certificate of Free Sale for pharmaceutical products.
- Requirements include premises, location, facilities, equipment, quality control, testing procedures, standard operating procedures, product security, manufacturing records, and recall procedures, and required self-inspections,
- Testing for product specifications(compendial/non-compendial).
- Heavy metals (Pb, Hg, and As)
- Microbial limit tests
Product Registration - Safety
- Preclinical data is required (animal studies, toxicology studies).
- Clinical safety data (SAE, ADR reporting from clinical studies, periodic safety update reports, and ADR monitoring).
- Non-permitted ingredients, such as phenylpropanolamine (ppa), penicillin (topical use), tartrazine, cyclamate, and Magnolia Officinalis.
- Screening of heavy metals in traditional products.
- Product information (warning labels, precautions, drug interactions, and adverse effects)
Product Registration - Efficacy
- Clinical efficacy data.
- Clinical trials (phases 2 and 3)
- Bioequivalence studies.
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Description
Test your knowledge on pharmaceutical regulatory practices and quality registration requirements. This quiz covers crucial topics such as natural product classification, clinical efficacy studies, and the role of regulatory pharmacists. Enhance your understanding of the regulatory landscape for medicinal products.
