Pharmaceuticals and Medical Devices

In pharmaceutical and medical device development, clinical trials are classified into four main phases designated with Roman numerals 1,11, III and lY The various phases of development trials differ in purpose, length and number of subjects involved. Phase I trials are conducted to determine safe dose levels of a medication, treatment or product (National Institutes of Health, 2002). The main purpose is often to determine an acceptable single dosage - how much can be given without causing serious side-effects. Phase I trials will also involve studies of metabolism and bioavailabity (Pocock, 1983). The sample size of a Phase 1 clinical trial is usually small, ranging from 10-80 subjects (National Institutes of Health, 2002 Pocock, 1983). 

Gad, S.C. (1996). Strategies for the application and interpretation of in vitro methods to the development of new pharmaceuticals and medical devices. Toxicol. Methods 6 1-12. 

The Pharmaceutical and Medical Device Agency (PMDA) of the MHLW is responsible for drug approval in Japan. 

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Pharmaceutical and Medical Device Agency (PMDA), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at the end of Phase II studies, before NDA, and consultation on individual protocols. 

PMDA Pharmaceutical and Medical Devices Agency (Japan)... 

Dr Yoshinobu Hirayama, Director, Evaluation Division 1, of the MHW Pharmaceuticals and Medical Devices Evaluation Centre confirmed that the current GAIYO (Expert Report) will be replaced by CTD Module II documents. He cautioned, however, that although the CTD provides a common content and format, there will be cases where differences would necessarily occur in dossiers for the three regions (e.g. there may be different dosage recommendations and different quality requirements). He sympathised its the impact on industry who would feel the burden of transition more than regulators and indicated that the transition time before the CTD... 

Responsibility for regulatory review has been passed to an Incorporated Administrative Agency, the Pharmaceutical and Medical Devices Agency (PMDA). PMDA also intensively checks applications for GCP compliance and reliability compliance. Another important role of PMDA includes an advice to sponsors on clinical trials and on which result can be submitted at the time of a new drug application. 

In Japan, prior to 1979 no formal regulatory guidance was available to western pharmaceutical companies and a marketing authorization of new drug products could not be obtained by non-Japanese manufacturers. The PMDA as we know it today was established in 2004 from the earlier Pharmaceutical and Medical Devices Evaluation Centre (PMDEC), the Organisation for Pharmaceutical Safety and Research (OPSR), and the Japanese Association for the Advancement of Medical Equipment (JAAME). 

In 1997, the Ministry of Health and Welfare extensively reformed the drug evaluation system and established the Pharmaceuticals and Medical Devices Evaluation Center affiliated with the National Institute of Health Sciences. Under the new system, the Center, through its specialized teams, conducts the evaluation of drugs for which different pharmaceutical companies have sought approval. 

The most commonly used samplers in the pharmaceutical and medical device industry are impaction and centrifugal samplers. The selection, appropriateness, and adequacy of using any particular sampler is the responsibility of the user. 

A list of all the line equipment that can influence the quality of the final packed product must be made. Some of the equipment commonly used in the pharmaceutical and medical device industries is given below with a short description. The list is an example of a simple line and is not complete for other products, but the same basic approach can be used. 

Packaging equipment used for pharmaceuticals and medical devices may be subjected to a wide variety of test procedures by the manufacturers of the packed products. Although all these tests have their value, it is essential to remember... 

Japan Pharmaceuticals and Medical Devices Evaluation Center (PMDEC)... 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

PMDA also consolidates all information regarding the quality, efficacy, and safety of pharmaceuticals and medical devices from manufacturers, medical institutions, and other sources. This information is scientifically reviewed and considered in the implementation of appropriate safety measures in collaboration with Ministry of Health, Labour and Welfare. Essential information is broadly disseminated to medical experts, manufacturers, and users of pharmaceuticals, medical devices, and others. 

Quality Assurance Manual for the Pharmaceutical and Medical Device Industry ... 

Chamberlain, R. Computer Systems Validation for Pharmaceutical and Medical Device Industries, Interpharm Press Buffalo Grove, IL. 

As confidence grew in the capability of the LAL test, as a screening tool for endotoxin pyrogen, pharmaceutical and medical device industries began to replace the rabbit test with the new in vitro test. The USP has continually revised the BET to keep abreast of advancements in LAL methodology. 

Baines, A. (2000) Endotoxin testing. In Handbook of Microbiological Control Pharmaceuticals and Medical Devices (eds R.M. Baird, N.A. Hodges Sc S.P. Denyer), pp. 144-167. Taylor Sc Francis, London. 

Baird, R. M., Hodges, N. A. Denyer, S.P. (2000) Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices. Taylor Francis, London. 

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