Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
(2002; 187 pages) View the PDF document
Table of Contents
View the documentACRONYMS
View the documentPREFACE
View the documentACKNOWLEDGEMENTS
View the documentEXECUTIVE SUMMARY
Open this folder and view contents1. DRUG REGULATION: OBJECTIVES AND ISSUES
Open this folder and view contents2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION
Open this folder and view contents3. PROFILE OF THE COUNTRIES
Open this folder and view contents4. REGULATORY FRAMEWORK
Open this folder and view contents5. REGULATORY CAPACITY
Open this folder and view contents6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE
Open this folder and view contents7. INSPECTION AND SURVEILLANCE
Open this folder and view contents8. PRODUCT ASSESSMENT AND REGISTRATION
Open this folder and view contents9. CONTROL OF DRUG PROMOTION AND ADVERTISING
Open this folder and view contents10. DRUG QUALITY CONTROL LABORATORY
Open this folder and view contents11. ASSESSING REGULATORY PERFORMANCE
Open this folder and view contents12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
Close this folderANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE
View the document1. Background information
View the document2. Drug regulation: overview
Open this folder and view contents3. Regulatory functions
 

1. Background information

Country information

BG1: Country: _________________________________________________

BG2: Area of country (square km): _______________________________

BG3: Type of government (federal or centralized/unitary): __________

BG4: Administrative divisions of country (number of provinces, states, districts):

_______________________________________________________________

Demographic and social and economic data

Demographic data

Figure:

Year:

BG5: Total population

   

BG6: Average annual growth rate of population

   

BG7: Urban population (%)

   

BG8: Life expectancy

   
 

(a) male

(a)

 
 

(b) female

(b)

 

BG9: Literacy rate

   
 

(a) male

(a)

 
 

(b) Female

(b)

 

Economic data

   

BG10: Gross national product (GNP)

   

BG11: Gross domestic product (GDP)

   

BG12: GNP per capita

   

BG13: Annual rate of inflation

   

Health information

Health status data

Figure:

Year:

BG14: Infant mortality rate (per 1000 live births)

   

BG15: Maternal mortality rate (per 100,000)

   

Health system data

 

Figure:

Year:

BG16: Total government health expenditure (million US$)

   

BG17: Total government sector health expenditure as % of GNP

   

BG18: Total value of international aid for health sector (million US$)

   

BG19: Total national health expenditure (million US$)

   

BG20: Total number of:

   
 

(a) government hospitals

(a)

 
 

(b) private for-profit hospitals

(b)

 
 

(c) private not-for profit hospitals

(c)

 
 

(d) other types of health care facilities (specify):

(d)

 

Pharmaceutical sector information

 

Figure:

Year:

BG21: Total government pharmaceutical expenditure (million US$)

   

BG22: Total national drug expenditure (government + household + international aid, etc.) (million US$)

   

BG23: Per capita drug expenditure (million US$)

   

BG24: Total value of domestic pharmaceutical production (million US$)

   

BG25: Total value of imports of finished pharmaceutical products (million US$)

   

BG26: Total value of imports of pharmaceutical active ingredients (million US$)

   

BG27: Total value of exports of finished pharmaceutical products (million US$)

   

BG28: Total value of exports of pharmaceutical active ingredients (million US$)

   

Health and pharmaceutical human resources

 

Figure:

Year:

BG29: Type and number of health professional training schools:

   
 

(a) medical school

(a)

 
 

(b) pharmacy school

(b)

 
 

(c) other relevant schools (specify):

(c)

 

BG30: Type and number of drug prescribers in the country:

   
 

(a) physicians

(a)

 
 

(b) dentists

(b)

 
 

(c) others

(c)

 

BG31: Total number of pharmacists (degree)

   

BG32: Total number of pharmacy technicians (diploma)

   

Pharmaceutical production status

 

Figure:

Year:

BG33: Pharmaceutical manufacturing plants:

   
 

(a) Total number of pharmaceutical manufacturing plants in the country

(a)

 
 

(b) Number of pharmaceutical manufacturing plants producing pharmaceutical active ingredients only

(b)

 
 

(c) Number of pharmaceutical manufacturing plants producing finished pharmaceutical dosage forms

(c)

 
 

(d) Number of pharmaceutical manufacturing plants packaging finished pharmaceutical dosage forms only

(d)

 

BG34: Total number of research-based pharmaceutical industries

   

BG35: Total number of generic pharmaceutical products (including branded generics) manufacturers

   

BG36: Total number of nationally owned pharmaceutical industries (government and private)

   

Distribution

 

Figure:

Year:

BG37: Total number of pharmaceutical:

   
 

(a) importers

(a)

 
 

(b) wholesalers

(b)

 

BG38: Total number of:

   
 

(a) government hospital pharmacies

(a)

 
 

(b) private for-profit pharmacies

(b)

 
 

(c) private not-for-profit pharmacies

(c)

 
 

(d) other drug dispensing outlets e.g. dispensing doctors clinics

(d)

 

Pharmaceutical products

 

Figure:

Year:

BG39: Total number of pharmaceutical products registered in the country1

   

BG40: Generic products, including branded generics, registered (as % of the total number of pharmaceutical products registered in the country)

   

1 In this guide the term "pharmaceutical product" is understood to include the finished pharmaceutical product, the device for administration where it is an essential part of the product, and the product information.

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Last updated: May 3, 2013