JAPAN TO INTRODUCE NOTIFICATION SYSTEM FOR MEDICAL PRODUCT CHANGES
The Japanese Ministry of Health, Labor and Welfare recently announced in October 2003, their plan for a notification system for minor changes in approved medical products. The guidelines for the notification system will be included as part of the revised Pharmaceutical Affairs Law (PAL) and is expected to be put in place by 2005. Under the notification system, manufacturers and sellers of pharmaceutical and medical products must notify the MHLW of minor changes from their approved product’s details.

Notification must be made to the MHLW should the medical product’s details change from those registered under the Master File. Any changes in the product’s name, dosage, manufacturing method, quality, effect, active ingredients, excipients, and materials used, need to be reported under the proposed system. The guidelines will also include what types of changes constitute minor changes. The ministry will provide a means for manufacturers and sellers to inquire if a medical product’s changes can be dealt with through the notification system. Medical products with major changes must go through a formal application process (partial change amendments) which must be filed with the MHLW for examination and approval.

PHASE I CLINICAL TRIALS FOR NEW DRUGS IN INDIA: PROPOSED AMENDMENT
A panel headed by Dr. R.A. Mashelkar, Director General of the Council for Scientific and Industrial Research (CSIR), recommended in its report that Phase I clinical trials be allowed in India concurrently as they are being conducted abroad. Phase I clinical trials involve testing new drugs on human volunteers after the completion of animal trials.

Currently, Schedule Y under the Drugs and Cosmetics Act of 1940 allows Phase I clinical trials to be conducted in India only on new drugs discovered in other countries when foreign clinical trial data is available. The Mashkelar panel has recommended amending Schedule Y to allow Phase I clinical trials to be conducted in India at the same time that they are conducted abroad.

According to the panel’s report, allowing concurrent Phase I clinical trials in India and aboard will allow new drugs discovered overseas to become more accessible to the Indian people. Conducting these trials will also help to determine the drugs’ effects on Indians and their genetic profiles. As more clinical trials are conducted in India, drug manufacturers abroad will also realize the lowered costs of conducting trials in India, thus, providing incentives to perform clinical trials in India.

However, the proposed amendment to Schedule Y has also raised concerns regarding ethics. Many are concerned that the poor in India may be willing to offer themselves up as “guinea pigs” in order to earn money from participating in clinical trials. In the past, India has been known for poor people who were willing to sell their organs in order to earn money. Thus, additional measures must be taken by the Indian government to prevent the exploitation of the poor should the proposed amendment be implemented.

CHINESE GOVERNMENT IMPLEMENTS NEW LAWS ON GENETIC RESEARCH
While other countries debated questions of ethics dealing with genetic engineering and research, China has been seen as a country which welcomed any type of genetic research with no questions asked. However, this previously held belief is changing. On October 1, 2003, new regulations took affect in China banning human cloning and placing new controls on genetic experimentation of human eggs and sperm for fertility purposes. The new laws also make for profit trading of human eggs and sperm an illegal act.

The actual effects of the new regulations will not immediately be known since they will largely depend on how stringently the Chinese government upholds the laws. For example, approximately two years ago, China’s Ministry of Health announced an official ban of all commercial trading of human eggs and sperm. However, this rule has largely been ignored and has not been enforced. Significant numbers of fertility clinics and some hospitals have been collecting, storing, and selling human eggs and sperm without obtaining government approvals or licenses.

The reason for China’s sudden interest in regulating genetic research is largely due to the government’s concern of becoming a “legal loophole” for the genetic research community worldwide. Without official regulations, the Chinese government would be helpless to control the type of research occurring within its borders. Foreign scientists wishing to avoid legal restrictions in their own country may choose to conduct ethically sensitive testing in China. By implementing the new regulations, China has effectively placed official legal boundaries on genetics research.

Chen Xigu, a scientist in Guangzhou comments, “This is good for the long-term development of this scientific field. Otherwise, it’s possible there could be a disaster before we figured out how this science can benefit mankind.”

SINGAPORE CREATES CENTER FOR DRUG ADMINISTRATION
Effective January 1, 2004, the Singapore Health Sciences Authority (HSA) launched a consolidated Center for Drug Administration (CDA). The center was formed as a result of a merger between two of HSA’s former professional centers responsible for the regulation and evaluation of medicinal products – the Center for Pharmaceutical Administration (CPA) and the Center for Drug Evaluation (CDE).

The CDA’s mission is to further rationalize and streamline the systems and processes for the evaluation and registration of western medicinal products in Singapore. Such procedures used to be completed by various arms of the CPA and CDE, but synergizing processes and systems is in line with HSA’s objective of providing seamless regulatory services.

The merger will not affect external operational interfaces for points of contact for product applications. The former CDE department responsible for that is now called the Innovative Therapeutics Group, and is part of the new CDA’s Product Evaluation and Registration Division.