east african community - ifpma€¦ · the east african community (eac) joint assessment procedure...

SOUTH SUDAN

UGANDA

RWANDA

TANZANIA

KENYA

BURUNDI

Transparency, efficiency and predictability

Efficient administrative team for the management of applications and queries

Single point of Contact in submission of dossiers

Only 1 submission to all EAC National Regulatory Agencies (NRAs) = access to minimum 2 markets and up to 5

Faster and harmonized regulatory approvals in the region

Final decision valid in all EAC Partner States NRAs

Enhance timely access to medicinal products in EAC countries

Reduction of cost for all parties

The East African Community (EAC) Joint Assessment Procedure (JAP) is aninitiative aimed at having joint assessment of applications and harmonized regulatory approvals in the region. The process is available to any industry applicants to register different types of pharmaceutical products across the EAC region through a single application. The procedure also allows for fast track registration of certain medicines.

East African CommunityOne people, one destiny

JUMUIYA YA AFRIKA MASHARIKI

WHY APPLY VIA THE EAC JOINT ASSESSMENT PROCEDURE

JOINT ASSESSMENT PROCEDUREEAST AFRICAN COMMUNITY

International Federationof PharmaceuticalManufacturers & Associations

D A Y 0

1D A Y 1 0

2

5.1 Send List Of Questionsto applicant

5.2 Responses to List Of Questions

E X T R A 1 8 0 D A Y S

3.1 Joint GMP Inspection

D A Y 4 5

3 Initial review

D A Y 3 6 0

8 Approval at National Level and issuance of Marketing authorisation certificates within 90 days

i f physical inspection is necessary

9 Publication of Marketing Authorisations by all NRAs and EAC Secretariat.

OVERVIEW OF THE PROCESS

APPLICANT Uganda NDATanzania Medicines andMedical Devices Authority (TMDA)

ALL NRAs NRA 1 EAC SECRETARIATNRA 2

D A Y 6 5

4 Peer review

D A Y 2 7 0

6 EAC Secretariat

D A Y 3 0 0

7 Issuance of the final EAC recommendation for registration. Confirmation letter is sent to applicant

D A Y 9 0

5 Assessment Session

maximum 3 rounds (each round = 180 extra days)

Applicable fees for EAC Partner States NRAs are available upon request.

ACTORS

Do you have further questions?

Would you like to submit an application for a product through the EAC Joint Assessment Procedure?

Please reach out to the EAC Secretariat for further assistance.

MORE INFORMATION

East African CommunityOne people, one destiny

JUMUIYA YA AFRIKA MASHARIKI

Tel: +255-27-2162100/14

Email: eacmrh@eachq.org

Screening and validation by TMDA. Verification of GMP status

Tanzania Medicines and Medical Devices Authority

Application submission to

Review followed by Joint Compile documents and send recommendations to

led by Uganda National Drug Authority (GMP lead)