ORIGINA / Evidence & Quality

Science does not
replace regulation.

Cosmetics, medicines, medical devices, and clinical investigations may follow different regulatory pathways. Classification precedes claims.

01 · Regulatory architecture

Classification precedes claims.

Cosmetics · Tanzania

Cosmetic products placed on the Tanzanian market are subject to applicable Tanzania Bureau of Standards (TBS) frameworks. ORIGINA does not claim TBS approval unless explicitly documented.

Medicines · Devices · Clinical trials

Medicines, medical devices, diagnostics, and regulated clinical investigations fall under applicable Tanzania Medicines and Medical Devices Authority (TMDA) frameworks where relevant.

01

Cosmetics

Product categories subject to applicable cosmetic regulatory frameworks, including Tanzania Bureau of Standards (TBS) requirements for cosmetic products placed on the Tanzanian market.

02

Medicines

Subject to applicable Tanzania Medicines and Medical Devices Authority (TMDA) frameworks where products meet pharmaceutical regulatory requirements.

03

Medical devices & diagnostics

Subject to applicable TMDA frameworks where products meet medical device or diagnostic regulatory requirements—distinct from cosmetic classification.

04

Clinical investigations

Regulated clinical research remains conceptually separate from cosmetic product marketing. Clinical trials follow applicable TMDA pathways where required.

Regulatory classification precedes claims architecture.

02 · Clinical research

Clinical research pathway

Where regulated clinical research is conducted, the pathway includes applicable regulatory authorization, ethics review, informed consent, participant safety, predefined endpoints, statistical methodology, adverse-event monitoring, data integrity, investigator responsibilities, and appropriate reporting—distinct from cosmetic marketing.

Important: Compliance work and framework alignment do not constitute regulatory approval unless explicitly documented. ORIGINA does not claim TBS Approved, TMDA Approved, or regulator approved status without underlying documentation.

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Follow the quality and claims framework.