Drug Regulation

Expedited Pathways

Draft process flow of expedited pathway: reproduced from the TGA Presentation ‘Prescription Medicines MMDR Reforms Overview and Designation Process: Expedited Pathways for Prescription Medicines’, 14 October 2016 


One of the outcomes of the ‘Review of Medicines and Medical Devices (MMDR Review)’ is the adoption of expedited pathways for approval of prescription medicines in Australia.

The TGA […]

By |October 18th, 2016|Drug Regulation|0 Comments

Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)

In light of experience, since the original guidance document was published in 2006, there are a number of changes under consideration in the draft guidance document ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’[i].

Broadly these include:

More specific requirements for immunogenicity assays
Investigation into the clinical significance of immunogenicity
Risk-based approach to immunogenicity with requirements for both […]

European Guidance with regard to Biosimilar Recombinant G-CSF

The European Medicines Agency (EMA) released a concept paper on 23 July 2015 with regard to revising the biosimilar guidance document on biosimilar recombinant granulocyte-colony stimulating factor (rhG-CSF).

The current EMA guidance document came into effect in June 2006 and consequently was one of the earliest European product specific guidance for biosimilars. The passage of […]

Regulatory Evaluation of Biosimilars

The first challenge with understanding the regulation of biosimilars is to recognise the broad array of terminology which is used i.e.

Similar Biological Medicinal Product (SBMP) (the term used by the European Union);
Follow On Biological (the term initially used by the FDA);
Subsequent Entry Biologics (the term used by Health Canada);
Similar Biotherapeutic Product (the term used […]

Australia and New Zealand Therapeutics Product Agency (ANZTPA) – What Next?

Again the proposed joint regulatory agency between Australia and New Zealand – the Australia New Zealand Therapeutic Products Agency (ANZTPA) has faltered. There has been discussion with regard to forming this joint agency since the initial agreement was signed between the two Governments in December 2003. The first attempt at establishing ANZTPA was unsuccessful […]

By |November 21st, 2014|Drug Regulation|0 Comments

Data exclusivity

Data exclusivity is a vexed issue: how to protect new innovations and additional clinical studies without the advantage of patent protection? Data Exclusivity in Australia is aimed at providing a 5 year window whereby a company can enjoy exclusive use of the data that they have generated without competition from generics.  The requirements are […]

By |November 13th, 2014|Drug Regulation|0 Comments

Orphan Drugs (Part 2)

The European Medicines Agency (EMA) has recently released an updated guidance document with regard to Orphan Drug Applications. The FDA and EMA have a common application form which covers application for Orphan Drug designation in both the US and European Union and parallel applications are encouraged by the regulator – principally to encourage the […]

By |October 8th, 2014|Drug Regulation|0 Comments

Orphan Drugs

Drugs which are developed for rare conditions are termed orphan drug and may be a medicine, vaccine or in vivo diagnostic agent.

In the early 1980’s it was recognised that there were a significant number of diseases which effected small patient populations and that the economics of developing drugs for these niche indications were unfavourable. […]

By |September 25th, 2014|Drug Regulation|0 Comments

Risk based approach to drug regulation

There are over 73,000 registered, listed and included medicinal products on the Australian Register of Therapeutic Goods (ARTG). With this large number of therapeutic goods it makes sense that the Therapeutic Goods Administration (TGA) uses a risk-based approach to the regulation of medicines.

Those products which are considered higher risk, such as prescription medicines (termed […]

By |September 2nd, 2014|Drug Regulation|0 Comments

International Conference on Harmonization (ICH): A global collaboration

No discussion of the regulation and development of medicinal products is complete without mentioning the critical role of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Prior to 1990, the technical requirements for registration of drugs were significantly different between the three major pharmaceutical jurisdictions – namely […]

By |August 30th, 2014|Drug Development, Drug Regulation|0 Comments