Regulatory Process

SMO-CLINICA can handle both the study approval at the country level and submission to local Ethical Committes.

Complete Regulatory process and timelines varies from country to country.

 Regulatory Submission Time (theoretical)



Country

CA

Submission

Timeline

Translation (protocol summary, ICF, drug labels, any docs given to patients)

Import License

Beijing, CN

SFDA

Separately

9 – 12 months

Complete dossier in Chinese
Reg. Docs, Insurance and Contracts

Required

Brazil

ENVISA

Parallel or separately

3-5 months

Portuguese
Insurance

Required

Czech Rep.

SUKL

Parallel or separately

60 days

Czech
Summary of trials with same drug

Required

Denmark

DMA

Parallel or separately

60 days

Danish
Insurance

If outside EU

Estonia

SAM

Parallel or separately

60 days

Estonian & Russian
Certificate

Required

Hong Kong, CN

HKMA

Parallel or separately

60 days

Chinese & English
Insurance, Reg. Docs, and contracts

Required

India

DGCI

Parallel or separately

3 months

Indian & English
Insurance, Reg. Docs, and contracts

Required

Lithuania

SMCA

Parallel or separately

60 days

Lithuanian
Insurance + contract

Required

Poland

CRCT

Parallel or separately

60 days

Polish;
certified translations and notarised copies of reg. Docs, delegations letters, insurance and contract

If outside EU