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In depth understanding of what is TGA 's GMP
In the pharmaceutical and health care industries, TGA's GMP is very important。 Its functions include evaluating new drugs, setting standards, determining testing methods, performing tests, issuing drug manufacturing licenses, supervising drug production processes, sampling drug markets, inspecting drug manufacturers, inspecting drug production records and handling complaints。 And so on, and TGA 's GMP is the GMP certification of the Australian drug administration。
TGA attaches great importance to the supervision of drugs. There are three main points: first, the evaluation of drugs before listing. All medicines and medical devices must be registered with the TGA before entering the Australian market to assess their risks. Next is the license certification of pharmaceutical manufacturers. Pharmaceutical manufacturers in Australia must be licensed by TGA and certified by GMP. There is the late regulation of the market. TGA has the right to carry out the sampling inspection of the drugs on the market so as to ensure that they meet the quality and safety standards.
According to the corresponding Australian law, all pharmaceutical manufacturers entering the market must be certified by the Australian GMP. The Australian GMP standard, published in 1969, is the third global GMP standard (after the FDA and WHO GMP). The GMP standard being implemented in Australia was published in 1990 as Australia's fifth GMP version. On the basis of this version, Australia began to gradually align its GMP standard with the standard. In June 1993, European GMP requirements for clinical trials of drugs were fully incorporated into Australian GMP standards. In January 1999, part of the annex of the European GMP standard was also incorporated into the Australian GMP standard. Through continuous improvement, the current Australian GMP standards are actually more than 30 common standards adopted by the European Union and the Asia-Pacific region.
When the company has passed the TGA's GMP certification, the product can enter the Australian market, at this time can also apply for product registration in Australia. The acquisition of TGA certificate will play a great role in promoting the development of the company's market and has a very important strategic significance for the company's development. The validity period of certificate is not uniform in TGA. Sometimes it is set to be 3 years, sometimes it is set to be 2 years, and it can be re-examined at any time during the validity period. It is not necessary to wait until the expiry date.