Professional Certificate in Regulatory Affairs of Herbs, Supplements, and Cosmetics

Professional Certificate in
Regulatory Affairs of Herbs, Supplements, and Cosmetics

The era of biotechnology has brought rapid development and progress in various industrial fields in Malaysia and around the world, this development includes the development of health products such as herbal medicines, health supplements, and cosmetics. The exponential regulatory system gives the impression that knowledge in the field of health product development is complex and difficult to understand. This causes many controversial issues regarding the results of health and cosmetic products. Therefore, the purpose of this course is to give exposure to researchers and industry in the registration of products at the National Pharmaceutical Regulatory Agency (NPRA) and to encourage the exchange of ideas among researchers and industry in the field of product registration so that negative perceptions related to the difficulty of registering health products such as herbal medicines, supplements and cosmetics can be reduced.

Explain

Explain the basic techniques and approaches for developing herbal medicines, health supplements, and cosmetics (C1)

Clasiffy

Classify permitted ingredients as well as classify products for registration of herbal medicines, health supplements and cosmetic products according to the regulation system in Malaysia (C4).

Adapting

Adapting the scientific values, halal status, risks, benefits, and ethics in healthcare and cosmetic products development (P6).

Duration

134 hours

Credit Hours

3 credit hours

Introduction of Professional Certificate.
Approaches in herbal research for the development of herbal medicine and health supplements.
General principles of quality assurance of herbs, herbal products, and cosmetics.
Safe use of herbs and herbal products as herbal medicines, health supplements, and cosmetics.
Basic of Omics approaches to herbal medicine research and development.
Preclinical evidence based (GLP) herbal products for health and wellness.
Road to clinical trial in Malaysia: Regulatory Aspects .
Regulatory requirements for herbal medicines, health supplements, and cosmetics.
Fundamental of Classification, Registration of Natural Products, Health Supplements, Cosmetic Notifications for Registration under QUEST 3+ System Ministry of Health Malaysia.
The halal aspect of herbal and supplement products, and cosmetics.
2-days Workshop.