Close on the heels of the global regulatory authorities such as US FDA, MHRA, EMA providing an update on the new regulations, the Therapeutic Goods Administration (TGA) of Australian has also issued the latest guidance to provide industry with norms on release for supply of medicines.
For India, Australia is seen as a vital market which cannot be ignored.
While Indian pharma has acknowledged the importance of Australian market, specifically from Karnataka, Strides Arcolab and Biocon are focusing on the region. The demand for branded formulations and biologicals provides immense opportunities for exports. Micro Labs and Medriech too has TGA compliant facilities which has given them a head start in its foray into the Asia-Pacific region.
The guidance document is developed in consultation with experts from the industry associations. In fact, it was the pharma industry which had indicated the need for TGA guidance on release for supply of medicines. This is because the Australian system of release for supply by an Authorized Person (AP) is different from the European system of batch release by a Qualified Person.
Consequently, Annex 16 of the current PIC/S Guide to Good Manufacturing Practice for Medicinal Products has not been adopted in Australia, leaving industry with an information gap that could be filled with a guidance document specific for the Australian situation with regards to release for supply of medicinal products, stated the TGA document.
With the adoption of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products from January 15, 2009 – there was a need to provide updates on several pre-existing requirements, for complex manufacturing and supply chain situations.
In order to provide a comprehensive overview on release for supply, the latest regulation has two parts. The Part 1 explains the general requirements and responsibilities regarding release for supply by an Authorized Person applicable to all TGA licensed and certified manufacturers and to Australian sponsors.
The Part 2 of the TGA guideline specifies specific considerations on how the general requirements described in Part 1 could be met for particular areas of manufacture, for example complementary medicines or sunscreens, or for different supply chains. The guidance document may also be applied to investigational medicinal products, subject to any difference in the legal provisions and more specific guidance in Annex 13 of the current PIC/S Guide to GMP.
This guidance document does not apply to products covered under the regulatory framework for biologicals which are derived from human cells or human plasma. However, this guidance does apply to medicines from biological origin, such as vaccines and biotechnology products. This guidance document does not address the official control authority batch release specified for certain blood and immunological products.
The TGA administers the Therapeutic Goods Act 1989, applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy when necessary. The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.