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REGISTRATION SYSTEMS- UGANDA NDA Noel Aineplan
7TH VICH OUTREACH FORUM DATE: 22ND JUNE 2016 VENUE: BRUSSELS, BELGIUM
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Content of Presentation
Introduction Drug Registration process Activities supporting Registration Ongoing initiatives Challenges
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AFRICA Map of Africa showing the location of Uganda
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Introduction NDA was established in 1993
The National Drug Authority And Policy Act(NDPA), Cap. 206, Laws of Uganda is the enabling law Governed by an Authority(Board of Directors) appointed by the Minister of Health Secterariat headed by the Executive Director carries out all activities
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Introduction Major Business Processes: Inspectorate & Enforcement
Drug Assessment & Registration Pharmacovigilance Quality Control Support functions- Legal ,PR, Finance, IT, Procurement etc
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Scope of Drug Regulation
Scope of regulation is in the definition of a drug: Any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes. Products regulated: Human Pharmaceuticals, Biologicals & Vaccines Veterinary Pharmaceuticals, Biologicals & Vaccines Nutritional substances Herbal Medicines Medical devices, Diagnostics and Sundries Public Health Chemicals
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Steps in REGISTRATION I Application for Registration Product dossier
Compliance Additional information and data Corrective actions Assessment Inspections Steps in REGISTRATION Retention, Variations , Pharmacovigilance , import and export control and post market surveillance Product dossier SMF
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World Health Organization
Process flow World Health Organization 10 January 2012 Application for Registration Dossier, Samples & SMF Information requested Applicant Screening Application accepted for assessment GMP Review of GMP Certification, Inspection reports, Site Master Files (SMF). Information requested Information requested Corrective and preventive actions Assessment Applicant Inspection Manufacturer Accepted Accepted NDA Website Final decision on Registration: CNF & Authority Retention Variations Pharmacovigilance Import & Export control Post market surveillance Listing on National Register NDA website 8 PQP-overview & update January 2012
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Receipt of applications
2 CDs (CTD format)- All documents are submitted in electronic format Screening for completeness Communication of missing information to applicant Receipt of full application (+ samples) and assessment fees Encoding (Assigning file numbers) GMP (Submitting application for inspection)
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Assessment steps 1st Assessment
2nd Assessment (Quality Assurance step) Additional information request sent out to the applicant Additional information received and assessed Plant inspcted for GMP and approved - Valid for 3 years At all stages, communication is made to the applicant.
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Presentation to CNF and Authority
Products are presented to the Committee on National Formulary (CNF) Recommendation made to the Authority (Board) for registration or deferment or rejection (The applicant has right to appeal) Approval for Registration or Rejection by the Authority (Board)
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Registration of product
Assigning registration numbers to the products approved for Registration The approved products are included in the National register Communication to the applicant on the decision of the Authority NOTE: Commitment by NDA on Timeline for registration: 3 months from receipt of a complete application for registration.
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Post Registration activities
These include: Retention, Variations , Pharmacovigilance , Import and Export Control, Post Market Surveillance. QC
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Importance of International Standards –VICH,DRAs
Encourages greater transparency and public availability of regulatory information Promotes confidence and trust in the regulatory system Applying the same principles to the consistent integration of the scientific reviews and decisions of other DRAs into the domestic review process.
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Ongoing initiatives Development of the Uganda National formulary.
Harmonization of Registration in EAC and adopting Common Technical Document (CTD) format in registration medicines- IVPS. Review and strengthen our registration guidelines in the areas of: the Active Pharmaceutical Ingredient (API), Pharmaceutical Development, Efficacy (Clinical trials and Bioequivalence) Increase in collaboration with International Bodies like VICH.
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Ongoing initiatives (continued)
Consideration and utilization of reliable regulatory decisions of other agencies, institutions and experts without compromising independency and the objective of capacity building. Utilization of risk analysis principles in: assessment of applications for registration of products and amendments/ variations Implementation of electronic system in DAR activities (evaluation, filing, communication) Training of NDA Technical staff in Assessment of Medicines for Quality, Efficacy and safety.
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Challenges Low staffing levels of Qualified Staff.
Integrated computer system. Lack of adequate Storage facilities for Dossiers and Samples.
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THANK YOU
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