Pharmaceutical Regulatory Standards Quiz

<p>Phase 2 and Phase 3 trials (D)</p> Signup and view all the answers

<p>Clinical efficacy report (B)</p> Signup and view all the answers

<p>To ensure that drugs meet regulatory requirements (C)</p> Signup and view all the answers

<p>Cost-effectiveness (D)</p> Signup and view all the answers

<p>Pharmacovigilance (D)</p> Signup and view all the answers

<p>Post-registration process (B)</p> Signup and view all the answers

<p>New Chemical Entity (B)</p> Signup and view all the answers

<p>Timely access to new drugs (A)</p> Signup and view all the answers

<p>Analysis (D)</p> Signup and view all the answers

<p>Harmonization of technical requirements (B)</p> Signup and view all the answers

<p>Standard dietary supplements (D)</p> Signup and view all the answers

<p>Scheduled Poison products (C)</p> Signup and view all the answers

<p>To supplement a diet and enhance health (A)</p> Signup and view all the answers

<p>Vitamins and minerals (B)</p> Signup and view all the answers

<p>They are derived from living organisms. (D)</p> Signup and view all the answers

<p>They are essentially similar to currently registered products. (D)</p> Signup and view all the answers

<p>Probiotics (C)</p> Signup and view all the answers

<p>They are considered health supplements. (B)</p> Signup and view all the answers

A healthcare professional who ensures medications and medical products meet strict regulations before being available to the public.

The primary aim of regulatory bodies is to ensure that medicinal products, both drugs and cosmetics, are deemed safe, effective, and of good quality.

A document outlining the registration process for medicinal products in a specific region. It serves as a guideline for pharmaceutical companies to navigate the approval process.

A type of drug that hasn't been previously registered and is a novel chemical entity.

A medicinal product containing a completely new active substance never previously registered by the regulatory authority.

A type of drug product containing active substances that are already registered, but in a new combination or formulation.

The process where a product is tested and analyzed for safety and efficacy before and after it's launched on the market.

A system that monitors the safety of drugs after they have been released to the market, collecting information on any adverse effects.

A certificate showing that a pharmaceutical product meets Good Manufacturing Practices (GMP) standards and has been approved for sale in a particular region.

A set of guidelines outlining the requirements for registration and control of cosmetic products, specifically in Malaysia, ensuring their safety and quality.

A process that involves reviewing clinical data, animal studies, and product safety data to assess the potential risks and benefits of a drug, as well as the appropriate use and labeling.

The evaluation of a medicinal product's effectiveness by analyzing clinical trial data, particularly Phase 2 and Phase 3 studies, which determine whether a drug works as intended.

Data obtained from controlled clinical trials, specifically Phases 2 and 3, which demonstrate the efficacy of a drug in treating a specific condition.

A product that is essentially similar to an already registered product in Malaysia, but doesn't include biologics.

Products made from living organisms like plants, animals, or microorganisms. They are used to mimic natural substances in the body and include items like vaccines and antibodies.

A product containing active ingredients listed in the First Schedule of the Poisons Act 1952 in Malaysia, requiring careful control and prescription.

Products containing active ingredients not listed in the First Schedule of the Poisons Act 1952 in Malaysia and are not health supplements, natural products, or cosmetics.

Products designed to supplement a regular diet and enhance the health function of the human body. They come in small, easy-to-take forms like capsules, tablets, and powders.

Products that are similar to registered products in Malaysia, but feature a new form or dosage of the same chemical entity. It can involve changes in dosage strength or administration methods.

A treatment involving the introduction of cells or genetic material into a patient's body to treat a disease.

Substances made by or derived from living organisms using biotechnology or other advanced techniques. They are designed to mimic natural biological substances in our body.