Promotional material, regulatory approval

Other responsibilities include applications for regulatory approval of clinical trials and ensuring that promotional material for a product is in line with its licence. 

The issue of any promotional material that is not in accord with the MA, is inconsistent with labelling approved by the regulatory authority and is misleading is a criminal offence imder the Medicines Act (1968) and carries financial penalties and potential for a custodial sentence. Conviction of such an offence usually leads to erasure from the Medical Register by the General Medical Council (GMC). 

In most countries, before promotional material can be used, it must be approved or certified for use. This certification is often by a scientific service that must ensure the existence of the proper internal procedures for certification of promotional material. This, in turn, ensures implementation of the legislation and compliance with the self-regulatory code. 

This activity often described as The Medical and Social Conscience of a company largely resides in the Medical Affairs department. In most large -and medium-sized pharmaceutical companies this responsibility lies with Medical Affairs. The review of all materials, whether detail pieces provided in person to physicians in practice, slide sets for speakers on behalf of the company, general promotional material that is disseminated via print, radio, TV or web must be reviewed and approved by internal committees comprised of Medical Affairs staff, regulatory and legal personnel. In addition to the company review, this material must be sent to FDA at least by the first day of use. Review by FDA s DDMAC should be sought for TV advertisements. 

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