The National Organization for Drug Control and Research ” NODCAR” is a component of the Ministry of Health established in the year 1976 under presidential Decree 382 /1976. Marketing authorization is not allocated to any products unless it obtain the necessary certificate of compliance from NODCAR.
NODCAR is the Egyptian National Quality Control Authority
To ensure that the products being manufactured , imported or marketed in Egypt are safe and effective , Chemical , Physical, Microbiological , Biological and Pharmacological Quality Control Tests are performed according to the type of product.
All procedures of analyses applied at NODCAR are focused to assure that the products tested conform to appropriate standards of identity, strength, quality and purity. All methods and techniques of analysis should meet certain basic criteria as adequate degree of accuracy, precision and specificity .In case of drugs described in pharmacopoeias, the pharmacopoeias monograph contains a statement of the minimal standards with which the individual drug must comply. For other drugs not included in a pharmacopoeia, the product license issued by the National Regulatory Authority should include a statement of standards, i.e. product specifications.
Therefore, and in accordance with the presidential Decree, NODCAR is entrusted with the responsibility of the Quality Control of:
- Pharmaceutical and Biological products.
- Raw materials.
- Medical Devices.
- Veterinary products.
- Household Insecticides.
- Medicinal Plants and Natural Products.
- Materials testing (packaging and filling materials).
Activities and Responsibilities
- Quality control of Pharmaceutical products, Cosmetics, Medical devices, Raw materials, Veterinary products, Household Insecticides, Medicinal plants and natural products.
- Analysis of samples of new products, products under registration and products that need re-evaluation to assess their compliance and standards required for ensuring their safety and effectiveness.
- Development of new analytical methods and products standards.
- Active contribution in the scientific activities, committees, conferences and seminars relevant to NODCAR’s specialization.
- Conduct scientific research and development aiming at constant refining of the testing methodology and researching ways to improve them. Collaboration with the universities and specialized institutions is an integral part of this activity.
- Continuous upgrading of the scientific capabilities of NODCAR’s personal through training programs and guidance provided by scientific advisors and consultants.
- Bioavailability and Bioequivalence studies and Bioresearch on animals to supply NODCAR with crucial information about the safety and effectiveness of the marketed products. Clinical testing is to be authorized by NODCAR and should follow the international standards and ethics.
- Issuance of Scientific publications concerning information on new products, regulations adopted concerning the of some products, side effects and adverse reactions of drugs.
- Review, evaluate and give advice on the scientific contents included in the information sheets of the products and general advertising on drugs and cosmetics especially information materials propagated to consumers.
- Within existing rules and regulations and in collaboration with other regulatory authorities
- Extend its services within the context of its specialization to other Arab and Regional countries subject to approval of the Ministry of Health and concerned authorities.
Assuring the good quality, safety, and effectiveness of the marketed – local and imported – products in addition to scientific researches and development.
Development and upgrade to be competent regulatory control laboratories by improving the quality of work and the performance of the staff at all levels.
- BSI certificate for ISO 9002/1994 standard in 1998, then the certificate was updated to ISO 9001/2000 in 2002 and the most updated certificate ISO 9001/2008.
- HPLC lab was accredited according to ISO/IEC 17025 standard in 2008.
- Now, NODCAR is aiming to gain International Recognition through International Accreditation and WHO Prequalification.