History of evolution of drug regulation

DR1: When was drug regulation first introduced in the country (year)?

_______________________________________________________________

DR2: Title and date of enactment of the first drug law/act/regulations of the country:

_______________________________________________________________

DR3: Mission/objective(s) of drug regulation at that time, if a written document/statement is available. Indicate the title and date of publication:

_______________________________________________________________
_______________________________________________________________

DR4: Important milestones in the development of drug regulation and/or drug legislation/regulations (What happened? When?):

Present drug regulation mission and drug legislation/regulations

DR5: What is the mission of national drug regulation at present? If there is a written document, indicate the title and date of publication.

_______________________________________________________________

DR6: Indicate below the title(s) and date(s) of enactment of the different drug legislation/regulations currently used to regulate drugs in the country, including international/regional conventions, schemes, etc. to which the country is signatory.

DR7: Is there a written National Drug Policy (NDP) of the type recommended by WHO?

Yes
No
Draft only

DR7.1: If yes, indicate the title and date of adoption of the policy document.

_______________________________________________________________

DR7.2: Does the NDP mention that it is the government’s responsibility to regulate drugs and to ensure the safety, quality and efficacy of drugs?

Yes
No

Organization

DR8: What body is responsible for the following regulatory functions?

DR9: What body coordinates drug regulation centrally at national level?

_______________________________________________________________

DR10: Is there an organizational chart for drug regulation?

Yes
No

DR10.1: If yes, collect a copy; if no, make a drawing to show the linkage between the different bodies responsible for regulatory functions based on the information collected.

DR11: Does the drug regulation system use the support of external experts/committees?

Yes
No

DR11.1: If yes, list below the committees/external expert groups (not individuals) that participate in regulatory functions and indicate their role:

DR11.2: Is there a written and accepted code of conduct for external committees/experts and staff with regard to conflict of interest?

Yes
No

DR11.3: If yes, indicate the title and date of publication of the code of conduct:

_______________________________________________________________

DR12: Does the government run any of the functions mentioned below?

DR12.1: Is the drug regulatory authority (DRA) also responsible for managing any of the functions mentioned under DR12?

Yes
No

DR12.2: If yes, indicate which function(s) is/are managed by the DRA:

_______________________________________________________________

DR13: What kinds of regulatory function(s) is/are carried out at the different government administrative (state, province, etc.) levels?

DR13.1: Are there any written materials describing the roles, responsibilities, functions, and powers of the regulatory bodies at the different government levels?

Yes
No

DR13.2: If yes, obtain copies.

DR14: Is there a system of reporting or information exchange between the regulatory authorities at the different levels?

Yes
No

DR14.1: If yes, obtain copies of the latest report.

DR15: Is there written material showing the regulatory and enforcement strategies applied in drug regulation?

Yes
No

DR15.1: If yes, obtain a copy of the material.

Human resources

DR16: What is the total number of staff working in drug regulation throughout the country?

a) technical staff _________________
b) administrative staff ____________

DR17: Do all the staff working in drug regulation have job descriptions?

DR18: Do the regulatory authorities have the power to hire or dismiss employees?

Yes
No

DR18.1: If yes, give reference to the document that gives such power:

_______________________________________________________________

DR19: Is there a human resources/staff development plan (training, career structure, etc.)?

Yes
No

DR19.1: If yes, give reference to the document.

_______________________________________________________________

DR19.2: How many people have been trained in the last five years (please indicate correct year) in the areas mentioned below?

DR20: How does the salary of the technical staff working in drug regulation compare to the salaries of people with the same qualifications/functions but working in the private sector?

DR21: Is there a staff shortage?

Yes
No

DR21.1: If yes, indicate the main reasons?

_______________________________________________________________

DR22: Is there a high turnover of DRA staff (continuity problem)?

Yes
No

DR22.1: If yes, how many people have left their jobs in the last five years?

DR22.2: If yes, what are the reasons for the staff leaving their jobs?

_______________________________________________________________

Financing

DR23: Is the government committed to drug regulation?

Yes
No

DR23.1: If yes, is there a specific budget allocated by the government for drug regulation?

Yes
No

DR23.2: If yes, what was the budget of drug regulation in each of the last five years (in US$)?

DR23.3: What was the source of the budget in the last five years (answer yes/no)?

DR23.4: If there is no specific budget for drug regulation, what was the estimated expenditure of the country for drug regulation in the last five years?

DR24: Is there a fee system for the regulatory services provided?

Yes
No

DR24.1: If the DRA has a fee system, indicate below the main services for which fees have been levied as well as the amount of fees charged:

DR25: Is the authority allowed to use the fees collected?

Yes
No

DR25.1: If yes, give reference to the document that gives the DRA power to use the fees collected?

_______________________________________________________________

DR25.2: What were the total fees collected during each of the last five years?

DR26: Is there a problem of financial sustainability?

Yes
No

DR27: Is there a financial audit system?

Yes
No

DR27.1: If yes, is it internal, external or both?

External
Internal
Both

Monitoring and evaluation

DR28: Is there a working system of self-assessment of regulatory activities within the DRA?

Yes
No

DR28.1: If yes, describe the system:

_______________________________________________________________

DR29: Are drug regulatory activities carried out on the basis of a work plan?

Yes
No

DR29.1: If yes, give reference to the last work plan developed and used:

_______________________________________________________________

DR30: Is monitoring/evaluation carried out to assess the implementation/performance of drug regulation?

Yes
No

DR30.1: If yes, give reference to the last monitoring/evaluation report:

_______________________________________________________________

DR30.2: Is the monitoring/evaluation done internally or externally?

_______________________________________________________________

DR30.3: What are the main weaknesses, problems and strengths mentioned in the last monitoring/evaluation report (indicate year of monitoring and evaluation)?

DR31 Is the submission of a performance report to the supervisory body a requirement?

Yes
No

DR31.1: If yes, what are the main weaknesses or strengths indicated in the performance report and the reasons given for them?

DR32: Is there legal provision for pharmaceutical product liability for drug-related death, disability or other harm to consumers (e.g. as in thalidomide)?

Yes
No

DR32.1: If yes, give reference to the title, date of enactment and article number of the legislation:

_______________________________________________________________

DR32.2: How many product liability cases have been recorded in the last 10 years? Indicate also the products reported.

_______________________________________________________________

Accountability and transparency

DR33: Are contacts between the DRA and the firms it regulates formalized?

Yes
No

DR34: Does the DRA have a system of accountability?

Yes
No

DR34.1: If yes, to whom is it accountable?

_______________________________________________________________

DR34.2: If yes, how is the accountability organized in relation to the following?

DR35: Is the DRA transparent in its decision-making?

Yes
No

DR35.1: If yes, how is transparency achieved with respect to the following:

DR36: Does political pressure have an influence on regulatory decisions in the country?

Yes
No

DR36.1: If yes, in which area and in what manner? Explain:

______________________________________________________________

DR37: Mention below the main constraints faced in carrying out the different regulatory functions:

Enforcement

DR38: Does the drug law provide for sanctions against offences?

Yes
No

DR38.1: If yes, what are the different types and ranges of sanctions provided?

DR 39: How many violations were registered and administrative measures and judiciary sanctions applied in the last five years?

If there is any specific and important information that is not covered by the above questions, please provide additional information as appropriate.