Regulatory Affairs

Merck Serono's RA&C department operates in one of the most stringent regulatory environments in the world, one that requires consistent highly professional standards of operation.

For an understanding of pharmaceutical legislation worldwide, some basic facts must be understood and kept in mind. Typically, pharmaceutical legislation constitutes regulations after the fact - their development being triggered by unwanted, sometimes disastrous events. Information and knowledge on the use of medicinal products increase exponentially, thus pharmaceutical legislation are proliferating at an ever-growing pace. This legislation allows the regulatory bodies to instigate processes to ensure compliance.

The RA&C department is responsible for ensuring good regulatory practice. That is, continuous compliance with the Therapeutic Goods Administration's (TGA) Therapeutic Goods Act and regulations, which are in place to facilitate registration of Merck Serono’s full portfolio of products. Our aim is to bring new products to market in the shortest possible time. The RA&C department has scientific and technical disciplines complemented by excellent communication and negotiation skills, and we work in partnership with the TGA. The department takes an active part in shaping the regulatory environment by participating in industry related working parties to evolve guidance documents.

In addition, we are also responsible for meeting quality assurance aspects of drug distribution nationally.

In Australia, the TGA, as part of the Commonwealth Department of Health and Aged Care, has responsibility for ensuring that prescription medicines, including biologicals, are safe and effective and in compliance with the Therapeutic Goods Act and regulations. Prescription medicines are registered under the provision of Section 25 of the Therapeutic Goods Act 1989 on quality, safety and efficacy. This act sets out all the legal requirements for the import, export, manufacture and supply of medicines in Australia. The act is supported by the Therapeutic Goods Regulations and various orders and determinations, which provide further details of matters covered in the act.

Essentially, any product for which therapeutic claims are made (unless they are specifically exempt or excluded) must either be registered or listed in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.