Austrilia Drug Products Registration

I、Project introduction

      1. Australian TGA registration

      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.

      2. Australian drug classification management

      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, almost all Chinese medicines listed by Chinese companies in Australia are registered according to 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 service content

      1. On-site inspection to understand the status quo

      (1) Understand the customer's policies, plans, goals and requirements regarding TGA application work;

      (2) Knowing the availability of the information required for the application documents;

      (3) Understand the GMP "software" and "hardware" compliance;

      (4) Based on the site visit, make an objective assessment and give an assessment conclusion;

      (5) Based on the actual situation of the enterprise, put forward general arrangements and discuss the policies and strategies for determining the certificate application project.

      2. Application documents

      (1) Submit a list of work tasks for the project;

      (2) Preparing an outline for the preparation of Chinese registration documents;

      (3) Training and guidance for the preparation of customer basic data, including: general control of drugs in Australia; basic introduction of drug registration in Australia; training content and requirements training for registration documents.

      (4) Review and confirm the basic information provided by the customer;

      (5) Prepare the registration documents and related application documents for the production of English;

      (6) Assisting in the submission of registration documents to TGA with the cooperation of the client's Australian Registration Applicant (SPONSOR);

      (7) Responsible for technical contact with TGA during registration and GMP inspection, and answer questions related to TGA;

      (8) Responsible for the supplement and amendment of the registration documents and other application documents during the application process;

      (9) Respond to the customer's Australian registration applicant's inquiry about the registration documents.

      3, on-site compliance check

      Standards and objectives:

      Guided and led customers to carry out rectification and improvement of GMP “soft” and “hard” parts on the production site with the submitted application documents, Australian GMP regulations and other EU GMP related requirements and guidelines, to help customers fully meet TGA's “site compliance”. The preparatory work for the sexual inspection was finally passed through the on-site inspection.

      Work content:

      (1) Cooperate with the client's Australian registration applicant to assist in the initiation of GMP on-site inspection;

      (2) Based on the Australian TGA GMP regulations and guidelines, the customer will be fully prepared for the GMP compliance inspection at the TGA official production site, including: GMP special training; 2-4 rounds of “software”, "Hardware" audit and rectification.

      (3) Providing joint “simulation pre-inspection” to the enterprise by experts, consultants and technicians;

      (4) Produce 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.

Ⅲ、the service program

      1. Applicant registration

      Registered applicants (SPONSOR) must first register with TGA Electronics to establish an information and data platform, and then apply as required. The process of registration is actually the process of conducting a technical evaluation of the information submitted.

      If the supplementary drug is applied through “registration” or “registration”, the following requirements should be distinguished:

     (1) A new supplement or a new supplement should be registered. The technical framework for the new supplementary drug requirements is the CTD format of the ICH. In comparison, the registration of new supplementary drug ingredients is simpler, and TGA has a clearer review time limit.

     (2) If the product ingredients are in the TGA supplemental drug list, you can go through the registration process. Supplementary drug registration is a method provided by the TGA to the applicant (Sponsor) platform, directly into the electronic office system, registration of drugs, prescriptions, processes, indications, and then directly obtain the ARTG registration number through format review.

      2. GMP Clearance and GMP inspection

      Before registering or registering the product, the Australian official must confirm that its production facilities and production processes comply with Australian GMP requirements, the so-called “GMP clearance” procedure, the GMP Audit process. Therefore, in order to be able to market drugs in Australia, it must first obtain the GMP-compliant approval through the Australian official-TGA- on-site inspection.

      3. Review content of product application

The core of the registration document review is whether the product meets the requirements of “safe, effective and quality”.

      4. Approval

      Once the GMP inspection and registration review meets the requirements, TGA can approve the product to be listed in Australia.

The specific procedures for TGA drug registration and GMP certification for Chinese products are as follows:

      Find or become SPONSOR→SPONSOR in TGA electronic registration → determine the dosage form and variety of application → SPONSOR proposes GMP Clearance inspection application → TGA on-site inspection → TGA inspection result and defect letter (within 20 days) → Manufacturer rectifies and returns within 4 weeks → TGA Satisfied and accepted → TGA to SPONSOR GMP Clearance documents / notification to producers → SPONSOR registered products → TGA review registration information → TGA GMP re-examination (on-site inspection or “desktop” review) → approval of product registration and issuance of GMP certificate → Product launch.