Drug Regulation in Botswana

Drug Regulation in Botswana

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Description: Drug regulations, Organogram, Functions of DRU, Medicine registration dossiers, Drugs Regulatory Unit of Botswana, SIAMED, pharmacovigilance, ADR monitoring, Clinical Trials, Interventions, PEPFAR, use of SIAMED, WHO Prequalification system, computer based registration system SIAMED.

Author: Lisa Maria Urio (Fellow) | Visits: 4900 | Page Views: 9882
Domain:  Medicine Category: Therapy Subcategory: Pharmacology 
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Lisa Maria Urio Pharmacist Registration Section

The DRU is the unit of the Ministry of Health responsible for ensuring that medicines ibl f i h di i used in the country are safe, effective and of good quality. To this end the unit is involved in the evaluation of all medicinal applications for registration, i i i inspection of facilities where i f f ili i h medicines are stored and distributed. The mandate extends to ensuring that once the products are registered, the quality of the circulating products is maintained.



















Name Dr. S. Selelo D S S l l Mrs. P. Tsiu Ms. S. Mogatle Mr. T. Mahupu Mr. K. Baki Mr. Z. Mr Z Joy Dr. N. Modutlwa Ms. L. Urio M Mrs. N K N. Kago Mr. S. Ramoroka Mr. L. Koitsiwe Mr. R. Ganetsang

Telephone Number +267 363 2064 267 +267 363 2821 +267 363 2381 +267 363 2378 +267 363 2380 +267 363 2380 +267 363 2830 +267 363 2383 +267 363 2376 267 +267 363 2378 +267 363 2383 +267 363 2378

Email address sselelo@gov.bw l l @ b ptsiu@gov.bw smogatle@gov.bw tmahupu@gov.bw kbaki@gov.bw zjoy@gov.bw zjoy@gov bw nmodutlwa@gov.bw lurio@gov.bw nkago@gov.bw k @ b sramoroka@gov.bw lkoitsiwe@gov.bw rganetsang@gov.bw

Registration Allopathic medicines Complementary medicines Medicines control Habit forming drugs (HFD) I Inspectorate GMP inspections i il /P t k ti Ph Pharmacovigilance/Postmarketing surveilance

� Receiving of application � Pre-evaluation coding and entry into the database �A i i Assigning application numbers and li i b d acknowledging receipt to the applicant � Evaluation/ Assessment � Communication of queries to applicants

� Re-evaluation of resubmissions after queries are communicated to the i i d h applicants � Pre registration discussions of the evaluation reports Preparation of reports for Drugs Advisory Board � Registration/Rejection/Deferred with the f d h h Drugs Advisory Board � Preparation of registration certificates and implementing other DAB decisions � Communication with the applicants

Drugs Regulatory Unit of Botswana implemented variation guidelines in June 2009 so any application before this date were not processed. Variation applications are received and entered into SIAMED(an electronic database). The Evaluator, using the Variations guidelines, evaluates the application and prepares the letter which notes the queries in the application.

Th evaluator th gives th l tt t a l t then i The the letter to second evaluator who evaluates to check for grammar and scientific correctness.

Second evaluator comments on the letter. Second evaluator gives the first evaluator the letter for finalisation. The evaluator then sends the letter of h l h d h l f queries to the applicant, within two weeks. Upon receiving an adequate response response, update the blue book if it's a variation which requires update of the blue book book.

Assist the Customs Officers at border controls to control import of medicines into the country. The Th responsibility of th unit i t vet all ibilit f the it is to t ll import requests from all importers to ensure that only medicines that are allowed into the country are imported

Relatively new ADR monitoring Developed tools to report and capture ADR reports (guideline report form) Sensitization of stakeholders (potential reporters of ADR) 3/4 of the country Data collection and processing Report generation for submission to WHO PMS plan is expected in the application.(Some companies are already reporting ADRs)

Process requests for exemption from registration of medicines for therapeutic use. use There are 400 applications per year and the activities involved include Receipt of applications Checking of registration status of the medicines E l Evaluation of information provided i fi f i id d Communication with applicants Regular meetings with border staff to impress g g p the importance of allowing only registered medicines

Receipt of applications Assessment of applications Preparation of reports for committee review Presentation of the recommendations to the DAB Monitoring of the trial as they commence M i i f h i l h No GCP inspections currently

In 2008 the DRU had a backlog of about 1500 applications, following the report by SCMS a retreat system was introduced to reduce backlog In December 2010, a new way of outsourcing for evaluation of applications was introduced which includes a component of transfer of skills and has a better monitoring system

Funds from other partners like PEPFAR have been used to train staff on evaluation of applications, use of SIAMED The U it Th Unit sought assistance from WHO ht i t f Prequalification system to train staff members

As of April 2011 there are 160 applications pending evaluation compared to 1500 in 2007 Currently there are 11 guidelines related t C tl th id li l t d to registration of medicines, compared to one guideline in 2008 Applications are now submitted in CDs as well as one hard copy Improved quality of dossiers and reports

Guidelines and application forms are now published on the Ministry of Health website SOPs are available for major activities A computer based registration system (SIAMED) is in use All d dossiers are stored i d i t d in dossier rooms i which have the appropriate packaging and shelves

A document management system (manual and computerized) is in place Registration certificates were issued from 2010 A sample management system is in place. Samples are now being sent to the NDQCL for testing All registered products are now being monitored for variations

g High attrition rate of staff Lack of experienced staff, majority of y staff have less than two years experience Inadequate staff Establishing timelines due to lack of historical data Poor transport availability

Lack of funds to conduct Good Manufacturing Practice inspection on M f i P i i i pharmaceutical manufacturers Lack of office space Lack of expertise for troubleshooting for the narcotics software The use of outdated legal framework in medicines regulation Challenges with transparency and efficiency of service delivery

Update list of products allowed in Botswana Update and develop other g p p guidelines Improve capacity of staff To monitor the quality of drugs as they enter the country.

Conduct two consultancies this financial year Update listed p p products Develop more guidelines Review system of recognizing registration from other countries