Regulatory control pharmaceuticals

ASEAN Regional Training Centre for QCL and WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals. 

The Medicines Act 1968 included the definitions of a clinical trial and of a medicinal product. Clinical studies involving healthy volrmteers did not meet this definition of a clinical trial and, as a result, did not come under the remit of regulatory controls. Such studies were subject to self-regulation by the pharmaceutical industry. Consequently, only the clinical trials in patients had to be covered by a clinical trial certificate (CTO. 

The creation of a process to meet FDA requirements is a multidisciplinary activity. Although the Chemical Process Development organization generates the core process, its shaping and implementation to meet the needs of all other parties involved (particularly Regulatory, Manufacturing, Pharmaceutical Sciences, and Quality Assurance) requires an extraordinary level of collaboration. The principal objective is to produce, and to demonstrate that you have indeed produced, a high-quality API in a well-controlled system of operations. 

Regulatory control covers issues such as MA holders and pharmacists being legally obliged to report to the competent MRA any suspected quality defects of medicines. Any expenses connected with a recall from the market should be paid by the MA holder. Doctors and MA holders must report to the MRA all side effects which a) are not mentioned in the SPC b) are serious or c) hinder the further administration of the medicine. Compliemce with GMP, GLP and GCP must be monitored by inspectors of the MRA, appointed by the Minister of Health for this purpose. For GMP, the NIP is specified the same is valid for GLP and GCP in draft Decrees of the Minister of Hecdth. Medicine wholescders and pharmacies are inspected by the Public Health Service officials (local pharmaceutical officers). 

Olaniyi, A. 1997. Drug and Food Regulatory Control in Towards Better Quality Assurance of Drugs and Foods in the 21st Century, eds. Olaniyi, A.A. and Adegbolagun, O.M. Department of Pharmaceutical Chemistry. University of Ibadan, Ibadan, pp. 112-125. 

Improving the Regulatory Control and Assessment of Traditional/Herbal Pharmaceutical Products... 

The issues involved in the necessary record keeping. Good manufacturing practice (GMP) and regulatory control that are associated with a seeded process in the pharmaceutical industry are sometimes cited as reasons not to seed. In response to an article endorsing this premise (Pessler 1997), the following rebuttal by C.B. Rosas (personal communication) summarizes his and the authors views on this topic. 

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