Key regulatory bodies and frameworks

What is regulatory compliance?

It is the process of following the laws, regulations, and standards that apply to an organization's industry and operations.

What is the purpose of regulatory compliance?

It ensures companies comply with legal and ethical requirements

What are the product categories under regulatory compliance?

Biologics, Pharmaceuticals, medical devices

What are biologics?

vaccines, blood products, gene therapies, monoclonal antibodies. Typically subject to stringent regulatory oversight

What are pharmaceutricals?

drugs produced via biotechnological methods like recombinant proteins

What are the regulatory pathways under regulatory compliance?

preclinical research, clinical trial, marketing authorization

What does preclinical research have to do with regulatory compliance?

It requires approval for animal studies, need to meet specific guidelines

What do clinical trials have to do with regulatory compliance?

must follow GCP standards and require approvals from regulatory authorities and ethics committees

What does marketing authorization on have to do with regulatory compliance?

There’s a rigorous process involving submission of extensive data on safety, efficacy and manufacturing practices. Approval process can be lengthy and have many phases of review

What is GLP?

(Good Lab Practice): involves the management and conducting of preclinical lab studies

What is GCP?

(Good Clinical Practice): involves the design, conduct and reporting of clinical trials

What are GMPs?

(Good Manufacturing Practices): a system for ensuring regulated healthcare products are consistently made and controlled according to quality standards.

Why must GMPs be followed by manufacturers?

to ensure that products have the safety, identity, potency and purity and quality that they claim to have

What is GDP?

(Good Distribution Practices): relates to proper handling, storage and distribution of biotech products