Clinical trials drug approval process

Section 8.7 explains the clinical trial and drug approval processes in Australia. 

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. 

An NDA submitted to the MHLW is reviewed by the PMDA. PMDA personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess comphance. In the process, the PMDA consults the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Results of the review are forwarded to the Pharmaceutical and Food Safety Bureau (PFSB), which prepares the final approval through the Minister of the MHLW. Figure 8.10 shows the drug approval process in Japan. The procedure for manufacturing and distribution of drugs for overseas manufacturers is presented in Fig. 8.11. 

It is of utmost importance that the scientific community acts according to ethical standards when clinical trials and animal tests are unavoidable. Implementation of biosimulation into the drug approval process is a great step towards this objective. 

A protocol is a series of clinical trials conducted under the same rules. One protocol— that is, one model for conducting studies—may be used at several centers during the drug approval process. Numerous different protocols are utilized in the overall NDA. 

Thalidomide, a new sedative, was associated with birth defects in thousands of newborns throughout Europe. Fortunately, the medication had not been approved for use within the U.S. In 1962, with the support of Senator Estes Kefauver, another health policy window was opened the amendments were passed to ensure that medications were both safe and efficacious. With the Kefauver-Harris Amendments, the effectiveness of a medication has to be proven by substantial evidence which includes adequate and well-controlled trials. For the first time, pharmaceutical manufacturers had to demonstrate a product s efficacy to the FDA. The Kefauver-Harris Amendments led the way for randomized clinical trials and the FDA drug approval process. 

Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act of 1938 Required medications to demonstrate their safety and effectiveness Created the FDA drug approval process Required randomized clinical trials for medications... 

Worldwide, there were an estimated 10 000 babies with phocomelia and other allied deformities, including over 500 in England. In the US the drug approval process had stalled because of its neurotoxic potential, but even there about 20 000 patients had been exposed to thalidomide during clinical trials, and there were seven deformities reported in this cohort. In late 1961 the drug was withdrawal from Germany and the UK, and over the next 10 months from most countries of the world. It continued to be available in Canada as late as April 1962. 

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