| History |
| 1. |
Created the Directorate of Drug Control in the month of March 1988. |
| 2. |
This was followed by laying the foundations and the administrative |
| 3. |
Created in 1989 to control pharmaceutical services in the departments of health in all provinces where it was gradually strengthened Besiadlp, doctors and technical assistants have a good experience as a result they follow training courses inside and outside the country by the Ministry of Health in collaboration with experts from the World Health Organization. |
| 4. |
In 1990 were created Department of Pharmaceutical Control Bureau and the Division of Clinical Pharmaceutical Control Clinical Hospital in Damascus in 1991 and in the Hospital Division of Dermatology and the brave-heart surgery in 1999 that includes physicians and specialists with the knowledge of medicine resident doctors. |
| 5. |
In 1993 was recognizing the jurisdiction of Clinical Pharmacology |
| 6. |
Was in 1995 in collaboration with experts from the World Health Organization rules for good manufacturing practice medicine GMP in the Syrian Arab Republic. |
| 7. |
In 1997 issued a guide (the quality control of medicine in the Syrian Arab Republic) the methodology for the inspection of pharmaceutical plants and self-control and by the supervisory body in the ministry and departments |
Functions of the Directorate of Drug Control |
| 1. |
The inspection of pharmaceutical plants and storage depots and distribution of medicines |
| 2. |
Control of pharmaceuticals locally produced and imported. |
| 3. |
Clinical control of pharmaceutical products. |
| 4. |
Implement the decisions of the Higher Technical Committee of the drug with respect to control of the affairs of medicine. |
| 5. |
Study and follow up complaints relating to national and imported medicines |
Inspection of plants and storage depots and distribution of medicines |
| 1. |
Evaluation of medicinal plants within a directory searched include technical requirements and health should be available in the laboratories of medicines in terms of construction, equipment and technical staff and laboratories, as well as conditions of good manufacturing practice for drug GMP Paradise raise its report to the Higher Technical Committee of the drug, which issued decision to give permission for the plant and production lines in it |
| 2. |
Study concession contracts submitted by local laboratories for manufacturing excellence from foreign companies world where emphasis is on the following important points: |
| 3. |
Reputation and long history of awarding the company. |
| 4. |
Scientific expertise and practical assistance from the company awarding of the technical staff in the local plant (transfer of skills). |
| 5. |
The company's responsibility to provide the local plant raw materials used by them. |
| 6. |
Oblige the company awarding control of a pharmaceutical control laboratories in addition to the Ministry of Health. |
The number of companies has become a major global manufacturing SK concession granted in local laboratories, 45 companies. |
| 1. |
Periodic field visits to the laboratory, during production to evaluate the performance of the work, and its compatibility with the requirements of the conditions of good manufacturing the drug GMP As the Directorate of Drug Control and services in the provinces out monthly inspections of all plants where the drugs are recorded observations and observations in the list of special inspections to follow up the work's progress at all stages of production, storage and self-censorship in the lab. |
| 2. |
Periodic inspection of storage depots and distribution of medicines to make sure that the application of good storage conditions. |
Control of pharmaceuticals |
Are controlled pharmaceuticals properly licensed as follows: |
| 1. |
Monitor the raw material first. |
| 2. |
Althoudertan watching the first and second of all new medicinal product are not allowed to put to the circulation only after the necessary analysis and control laboratories in pharmaceutical research and production of reports which include the acceptance of results and compliance with the constitutional world. |
| 3. |
Althoudertan watching the first and second of all new medicinal product are not allowed to put to the circulation only after the necessary analysis and control laboratories in pharmaceutical research and production of reports which include the acceptance of results and compliance with the constitutional world. |
| 4. |
This is followed by the subsequent control of programmed pharmaceuticals that are in circulation and use, where each month raise at least 500 samples taken randomly from the storage depots and distribution of drugs and pharmacies and health institutions to ensure their effectiveness after the passage of time and exposure to the atmosphere by various natural factors. |
The imported drugs shall require samples from storage and is displayed by the program and within a particular system a decision of the Technical Committee of the drug by the various factions pharmaceutical.
|
Displays the results of analysis of preparations that appear where any disruption to the Commission on the study of drugs that are local to consider these reports, and raise the appropriate action based on proposed control system and effective decisions, which could include: |
| 1. |
Withdraw the product from circulation. |
| 2. |
Stop licensing and manufacture of the drug. |
| 3. |
Stop the production line. |
| 4. |
Stop the plant entirely. |
Clinical control of pharmaceutical products |
Control procedures implemented by the Department and the Division for oversight, which includes clinical and medical specialists is currently number 8 the number of resident doctors and four assistants, 2 technicians (the jurisdiction of drug control, laboratory, nursing) chemical number 1. The department has four units
|
| 1. |
Research Unit studies and drug information. |
| 2. |
Monitoring Unit side effects and medical errors. |
| 3. |
Unit clinical clinics. |
| 4. |
Unit quality control. |
Objectives |
| 1. |
Rehabilitation and training of resident doctors of the jurisdiction of Clinical Pharmacology. |
| 2. |
Medicine post-marketing surveillance through clinical studies of pharmaceutical products locally produced and imported to assess their effectiveness and ensure safety. |
| 3. |
Assess the effectiveness of pharmaceutical and health clinical terms |
| 4. |
Provide drug information, preparation of guidelines for the treatment of drugs. |
| 5. |
Early detection of side effects and drug interactions is not known. |
| 6. |
Detected an increase in the incidence of side effects known and written in the scientific literature |
| 7. |
Increase awareness about the side effects and medical errors. |
Classified as clinical studies carried out by the Service under the fourth phase of clinical studies in the world (studies of supervision or control post-marketing), and include: |
| 1. |
Clinical studies are continuing on some factions pharmaceutical quality (cardiovascular drugs, antibiotics, hormones, sugar Antipyrine "oral and insulin", anesthetics, drugs, neuropsychiatric, Alseromat, eye drops). |
| 2. |
Clinical studies according to the complaints. |
| 3. |
Clinical studies based on decisions of the Technical Committee and for some key drugs, quality and expensive before the IPO. |
| 4. |
Clinical studies for the registration of product imported. |
Clinical studies conducted in accordance with the foundations of good clinical practices in terms of design, implementation, monitoring, termination and analysis and reporting and documentation of the studies. So far been applied to studies Surayrah 200 medicinal product, has shown the results of studies conducted so far that the pharmaceutical formulations similar to the national standard foreign. Has been successful to start the program for monitoring side effects on 16/9/2000 was informed the World Health Organization as of 3/10/2000 has been designed following forms: |
| 1. |
Follow-up to form the side effects. |
| 2. |
Form of medical mistakes. |
| 3. |
Form follow-up drug quality. |
Directorate of Drug Control has three times the award Basil al-Assad of health and scientific research in the field of drug monitoring in clinical trials. |
Publications |
| 1. |
Promising good manufacturing practice in the pharmaceutical industry GMP 1995 |
| 2. |
Program quality control of medicine in the Syrian Arab Republic (manual inspection). |
| 3. |
Ensure the quality of medicines and good manufacturing practice for preparations sterile 1996. |
| 4. |
Medication Guide National Syrian Arab Republic, 1999. |