Legislation implementation experience of belarus
Download
1 / 10

LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS PowerPoint PPT Presentation


LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS. Gennadi Vasilyevich Godovalnikov – Director RUE “Center for Expertise an Researches in Health Care”, candidate of pharmaceutical sciences. CONTROLLING-PERMISSIVE SYSTEM OF DRUGS CIRCULATION. Ministry of Health of Belarus. Decision making.

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.

Download Presentation

LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Legislation implementation experience of belarus l.jpg

LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS

Gennadi Vasilyevich Godovalnikov – Director RUE “Center for Expertise an Researches in Health Care”, candidate of pharmaceutical sciences


Controlling permissive system of drugs circulation l.jpg

CONTROLLING-PERMISSIVE SYSTEM OF DRUGS CIRCULATION

Ministry of Health of Belarus

Decision making

Minister of Health

Deputy Minister of Health

Main Department for Pharmacy and medical equipment

Republican Unitary Enterprise «Center for Expertise and Researches in Healthcare»

Pharmacology Committee of the Ministry of Health

Pharmacopoeia Committee of the Ministry of Health

Development of draft decisions

Commission on medical immune-biological drugs


Structure of rue center for expertise and researches in healthcare l.jpg

STRUCTURE OF RUE «CENTER FOR EXPERTISE AND RESEARCHES IN HEALTHCARE»

Director

Deputy Director on Drugs

Deputy Director on medical equipment

Deputy Director on on hygienic registration

Drugs Department

Department for Licensing and Inspection

Department for medical equipment

Department for hygienic regulations and registration

Head of Department-Pharmacology Committee Secretary

Deputy Head of Department-Pharmacopoeia Committee Secretary

Republican reference and analytical laboratory

Department Employees

Pharmacology and Pharmacopoeia Committees’ experts


Slide4 l.jpg

CLINICAL TRIALS IMPLEMENTATION

Total Number 199 (as of 26.09.2002)


Slide5 l.jpg

1992 – INITIATION OF INDEPENDENT CLINICAL TRIALS OF DRUGS

Clinical trials of drugs in Belarus


Slide6 l.jpg

BIOLOGICAL EQUIVALENCE TRIALS OF DRUGS


Slide7 l.jpg

974

1000

900

779

800

700

600

476

500

400

300

217

213

204

200

122

87

100

0

Russia

Belarus

Germany

India

Poland

France

Hungary

Latvia

Total 5271 as of September 26, 2002

REGISTRATION OF DRUGS IN BELARUS


Slide8 l.jpg

Baltic countries

3%

Belarus

15%

Foreign

production

50%

CIS

32%

Total5271 as of September 26, 2002

REGISTRATION OF DRUGS IN BELARUS


Slide9 l.jpg

LICENSING OF PHARMACEUTICAL ACTIVITIES

Data as of 01.07.2002


Slide10 l.jpg

DRUGS QUALITY CONTROL

Most often met drugs that were indicated as adulterated:

2000 - Nystatin tablets (7), Noshpatablets (5), Summamedpowder (3), Terzhinan vaginal tablets (8), Trichopol tablets (10)

2001-Biceptol tablets (17), Hystaktablets (5), Nystatin tablets (9), Trichopol tablets (9), Essencialle Н capsules (12), Festal dragee (13), Piprolet tablets (7),

9 months of 2002 года - Essencialle Н capsules (5),Mesim (8), Festal (8), Cyston (1), Trental (5)


  • Login