Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Malaysia product registration

Applications for registration, submission of data, references cind all other correspondence pertaining to product registration can be submitted in Bahasa Malaysia or English. [Pg.354]

Dr Fudziah Ariffin, Head, New Drug Unit, Centre for Product Registration, National Pharmaceutical Control Bureau, Petaling Jaya, Sengalor, Malaysia Temporary Adviser )... [Pg.477]

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. [Pg.64]

In Venezuela, there is no official fast-track system. However, brief-mode registration is available for generic products for which a bioavailabilily study has been undertaken. Similarly, Malaysia has an abridged procedure for registration of products classified as non-scheduled poisons. This type of simplified procedure does not, in essence, differ from the use of less stringent registration requirements for certain categories of products as seen, for example, for herbal medicines in Australia and the Netherlands. [Pg.75]

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... [Pg.93]

Trading with Malaysia holds many attractions. It is the most prosperous country in the Far East, after Japan. Economically progressive, it has plenty of natural resources, including timber, tin, rubber, petrol and gas, palm oil products, and spices. Indeed, one can say that Malaysia is also a land of plenty. It enjoys a parliamentary democracy, constitutional monarchy and freedom of the press. It has a well-structured healthcare system, and its registration regulations are tailored to encourage multinationals to invest in the country. [Pg.683]

The relationship between UV-B radiation and skin cancer is by now well documented and accepted. The US EPA has estimated that each 1 % decrease in stratospheric ozone concentration will result world wide in a 2% rise in cutaneous malignant melanoma. Among the Asian and Pacific region, people of many countries, such as Australia, New Zealand, South Pacific Islands, Indonesia, Malaysia, Philippines, Thailand, etc, are the most vulnerable to the exposure of UV-B radiation. For example, between 1980 and 1991, when the growth of CFCs production was the maximum, melanoma cancer registration rates in New Zealand increased by 22% (ESC AP, 1995). [Pg.152]

A review is presented of discussions which took place at the International Seminar on ISO 9000 for Rubber and Rubber Products held at Ooty, India, December 1995. Discussed are the four primary uses for ISO 9000 as a guidance for quality management, contractual agreement, second party approval or registration and third party certification or registration, and the use of quality records to provide evidence to demonstrate conformity. Details are given of the number of rabber companies in Malaysia, Indonesia, Thailand, Sri Lanka and India who have obtained certification. [Pg.55]


See other pages where Malaysia product registration is mentioned: [Pg.122]    [Pg.342]    [Pg.30]    [Pg.47]    [Pg.55]    [Pg.73]    [Pg.75]    [Pg.75]    [Pg.77]    [Pg.83]    [Pg.105]    [Pg.125]    [Pg.342]    [Pg.235]   
See also in sourсe #XX -- [ Pg.499 ]




SEARCH



Malaysia

Product registration

Registration

© 2024 chempedia.info