These guidelines publish the regulatory requirements for authorizing the emergency use of a Medical Product (Allopathic Medicines, Biological Medicinal Products and Medical Devices) during a declared public health emergency. Such emergencies shall include, but not limited to, a heightened risk of affliction or attack on the life, health, safety and security of the general public or any incident with a significant potential to affect national security.

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The Code exists to ensure that the advertising of therapeutic goods to the public is conducted in a manner that:
• Promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse
• Is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance
• Supports informed health care choices
• Is not inconsistent with relevant current public health campaigns

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This guidance aims to:
• Provide a list of common manufacturing steps that validate within the various TGA product registration/listing systems
• Provide an interpretation for the common manufacturing steps from a GMP clearance perspective
• Provide clarification around common manufacturing step group terms and the individual manufacturing steps associated with each group which validate in the product registration/listing systems
• Reduce validation errors experienced within the product registration and listing systems

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Applications to change an Australian Register of Therapeutic Goods (ARTG) entry for a registered complementary medicine (RCM) are categorised into five levels (CN and RCM C1 to C4).

All applications for changes to registered complementary medicines attract an application fee. For certain applications a separate evaluation fee is also payable.

The Registered complementary medicines (RCM) changes tables are a tool to help you obtain essential regulatory information about the proposed change for your Registered complementary medicine.

The RCM change tables consist of the following change types:
• Table 1: RCM labelling (including package insert) and product detail changes
• Table 2: RCM sponsor changes
• Table 3: RCM formulation changes – active ingredients
• Table 4: RCM formulation changes – excipient ingredients
• Table 5: RCM quality control changes – finished medicine specifications
• Table 6: RCM quality control changes – starting material specifications
• Table 7: RCM packaging changes
• Table 8: RCM manufacturing changes – finished product
• Table 9: RCM Consumer Medicine Information (CMI) changes
• Table 10: RCM Product Information (PI) changes Table
• Table 11: Other RCM changes

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Below contents should be included in CTD module 2,3,4 & 5

CTD Module 2:Registered complementary medicines

  • Quality summary
  • Nonclinical overview
  • Clinical overview including risk benefit analysis of the medicine

CTD module 3: Quality information for a new registered complementary medicine

  • Active ingredient quality information
  • Product quality information

CTD module 4: Nonclinical data for a new registered complementary medicine

  • Pharmacology
  • Pharmacokinetics
  • Toxicology

CTD module 5: Clinical data

  • Pharmacology studies
  • Efficacy studies
  • Safety studies
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