10. Time/flow chart
The proposed process for restructuring is laid out in Table 2. The principles are that the process should begin immediately, and that the deadline for the new system to be in place and fully operative should be January 1st, 1999.
This target will require resources from both the Department of Health and other sources, but the Review Team does not believe that the sums likely to be involved will be excessive, particularly since the investment will rapidly result in the creation of a system which to a large extent will be self-financing.
TABLE 1
LONG-TERM ALLOCATION OF RESPONSIBILITIES FOR MATTERS RELATING TO MEDICINES AND ANALOGOUS PRODUCTS
| Minister of Health: | Approval of final drafts of Law Approval of regulations Appointment of members of Medicines Regulatory Authority Approval of National Medicines Policy All decisions on individual issues of policy |
| Department/Directorate: | Drafting of Laws and Regulations Drafting of Policy proposals for Minister Drafting (with TMCC/MRC) of policy on clinical studies Drafting (with DoAgr) of policy on veterinary drugs Development of Drug Information/Rational Use System Promotion of drug utilization studies to support policies Study of information system on medical devices/materials |
| Med. Regulat. Authority | Assessment/approval of new and modified drugs (Expert
Technical Committee 1) Assessment/approval of complement/tradit. products (Expert Technical Committee 2) Efficient registration of generic/parallel products Ongoing review of registered products Development of guidelines for applicants Maintenance and development of evaluation standards Development of external contacts Mobilization of international resources |
| University centres | Expert evaluations/peer review for control authority Enhancement of Adverse Reaction Monitoring (with MRA) Drug Utilization Studies (for Department) |
| Inspectorate of Medicines | Inspection of pharmaceutical plants Inspection of importer and traders Inspection of individual drugs on sale |
To be determined:
Drug Regulatory Agency or Medical Research Council to handle applications to conduct clinical drug studies
TABLE 2
Schedule for re-structuring.
| Time | Task | Directorate | Involving | (T)MCC | Involving |
| immediately | change management | -informing/ retaining staff
-briefing industry |
Department | informing/ retaining MCC experts | consultants |
| immediately | creating temporary structure | temporary management appointments | Department | temporary chair + council
(TMCC) |
Minister, Dept, ?consultants |
| establish temporary operating procedures | -joint meeting with TMCC | -joint meeting with Directorate | |||
| immediately - May, then ongoing | - temporarily suspend
intake of new applications except in urgent cases -clear backlog -define workload |
-restructure Secretariat -inventory of applications -inventory of complementary medicines |
-frequent TMCC meetings to prioritise and process applications | TMCC | |
| April/May | expanding capacity | fill vacant posts, create new ones | -tender for evaluation groups and assessors | Department + current evaluation committees | |
| dealing with applications for NCEs, generics, adaptation of licenses | -develop priority list -streamline administration |
-develop priority list -evaluate and review applications |
TMCC and Secretariat
new evaluation groups |
||
| May-June | creating new structure | -recruit permanent head, lawyer, financial manager | -Department | -recruit Chair of Board | Dept. + Minister |
|
|
-legislative amendments | perm.head + lawyer + TMCC + Justice + Minister | -recruit Board -recruit ETC1 -recruit ETC2 |
Dept. + Minister + Chair(s) | |
| June-August | -develop operating manual -financial analysis -fee structure -plan IT needs |
-perm. head -?external -external +financial manager -external |
|
||
| as above | creating new Inspectorate | -recruit head -as above |
Department + others | ||
| commence April - ongoing | dealing with complementary medicines | -legislative amendments -working parties to set standards |
-see above -Department |
-review of toxics list -start developing manufacturing standards where these do not exist |
TMCC +ETC2 -working parties |
| May - then ongoing | negotiate procedure for clinical trials | -meet with MRC, TMCC, Dept of Health | |||
| May-June | veterinary medicines | -establish new VMAC -establish technical secretariat |
DOH + Agriculture -Agriculture |
||
| August -September | drug safety monitoring | -contract external group | |||
| October | new MRA meets | adaptation of standards and procedures | new MRA meets | ||
| medical devices | commission to review | ||||
| January 1999 | new MRA operates | TMCC handover to Board and EAC | Board, TMCC, ETC1 and 2 | ||
| 1999 | drug information, utilisation | Commission to review needs |