Regulatory aspects for Biologic Product licensing in Australia
Journal Title: International Journal of Drug Regulatory Affairs - Year 2019, Vol 7, Issue 2
Abstract
The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: • Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). • Explains the Australian regulatory requirements for supplying of Biologicals • Explains what is required for the market authorization as per TGA especially for Biologicals.
Authors and Affiliations
Sanjeev Kumar Maurya, Vikesh Kumar Shukla, Sunny Kumar Maurya, Prachi Kaushik, Indu Maurya
Keywords
Related Articles
- EP ID EP625605
- DOI 10.22270/ijdra.v7i2.310
- Views 114
- Downloads 0
Transnail drug delivery device:A prominent approach for Onychomycosis therapy
Onychomycosis is often challenging therapeutically and demands a multipronged approach both in terms of systemic as well as topical delivery. The conventional treatment modalities available for onychomycosis are marred w...
COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.
To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows g...
REGULATORY STRATEGY FOR REGISTRATION OF COMBINATION PRODUCTS TO US-FDA
In pharmaceutical industry all the healthcare products are categorized into Drugs, Devices, and biologics and they are regulated by their respective departments of the regulatory authorities. Due to more and more develop...
NEED FOR DRUG PRICE CONTROL IN INDIA
India is one of the developing countries. A substantial proportion of population of this country is largely exposed to the drug market whose purchasing power is extremely low. Around 42% population of this country lives...
Drug regulatory paradigm and challenges for Medical devices in India
The medical device industry in India has made speedy growth in the last few years but lag behind as compared to developed nations like USA, UK, etc. The government has taken the right step by separating the medical devic...