Ⅰ、Australia TGA certification
According to the Therapeutic Goods Act 1989, all Australian-listed medical supplies (drugs and medical devices) must be registered or registered with the Australian Medical Supplies Administration (TGA) in accordance with the relevant requirements. After being registered (Australian Register of Therapeutic Goods, ARTG), it can be legally listed.
According to the degree of risk, Australia classifies drugs. The drugs are classified into prescription drugs, over-the-counter (OTC) drugs, and supplementary drugs.
The term "drug" as used herein refers to a pharmaceutical preparation. Raw materials are not independently registered and certified, and their quality and safety evaluation is part of the evaluation of the registration of the drug. TGA also performs GMP certification on APIs as needed.
A "prescription drug" is a drug that must be obtained by a doctor's prescription. It usually has high biological activity and has a high safety risk to patients. TGA imposes strict controls on the listing or import of prescription drugs.
"Over-the-counter (OTC)" is a drug that has been clinically proven and evaluated by government authorities as being safer than prescription drugs. These drugs do not require a doctor to prescribe the drugs that patients can choose. TGA implements relatively loose management of prescription drugs for the listing or import of over-the-counter drugs.
“Supplementary medicine” refers to a product whose composition is natural, has a traditional application, has a positive influence on the structure and function of the human body, and is safe to use. Chinese herbal medicines, vitamins, amino acids, minerals, etc. are the mainstay of supplemental drugs. Another characteristic of supplemental drugs is that they have strict restrictions on the indications of indications and curative effects. Words such as "treatment" and "cure" are not allowed to be claimed, and are generally described by words such as "improvement, assistance". The Australian authorities have detailed requirements on how to determine the claimed indications and their efficacy.
Australia's “supplemental medicines” are identical in substance to US “dietary supplements” and Chinese herbal and health foods, but their legal status is “drugs”, which can claim their use and efficacy to a greater extent.
Australia is one of the few countries in the world that recognizes Chinese medicine. At present, most Chinese medicines listed in Australia are registered with Chinese medicines in accordance with supplementary medicines.
Whether it is a “prescription drug” or an “over-the-counter drug (OTC)”, if you want to list in Australia, you must fulfill the registration procedure (Register). The “supplementary drug” can be registered or registered according to the specific situation. Can only be listed in Australia after passing the assessment and passing the GMP compliance check.
Ⅱ、the project objectives
During the time agreed with the customer, Kanglihua guided and led the customer to carry out the rectification and improvement of the GMP “soft” and “hard” parts of the production site with the submitted application documents, Australian GMP regulations and other EU GMP related requirements and guidelines. To help customers fully prepare for the TGA's “site compliance check” and finally pass the on-site inspection.
The work includes: 1. Cooperating with the client's Australian registration applicant to assist in the initiation of GMP on-site inspection.
2. To assist customers in comprehensively preparing for the GMP compliance check at the TGA official production site, based on the Australian TGA GMP regulations and guidelines.
3. Provide joint “simulation pre-inspection” to the enterprise by experts, consultants and technicians.
4. Make the factory master file (SMF) necessary for on-site inspection.
5. Provide on-site technical and technical translation support when TGA officials in Australia conduct on-site GMP compliance inspections of production facilities.
6. Guide and assist customers to correct and prevent inspection defects (CAPA) and give back to TGA.