The European Medicines Agency (EMA) has said that it will launch an investigation into the way drug maker Roche manages its safety reporting system.

The EMA said that it will work with local and national medicines authorities in the European Union region to assess possible impacts on patients. The agency will probe "deficiencies" in the safety reporting system and determine whether it had any impact on the risk-benefit profile of any of its products involved in the investigations.

The agency said that there is no need for the patients or the health sector professionals to take any action on the mattes as there is no negative impact known at present. It is believed that the investigations are a routine exercise of the EMA and not due to any specific incidence involving the company.

The investigations by the EMA were announced following a report by the UK medicines regulatory authority (MHRA). The UK body had conducted inspection of safety reporting systems at the company and had found deficiencies in the mechanism.

The MHRA had said that it has found around 80,000 patient reports for medicines marketed by Roche in the USA, which were not reported. The reports include more than 15,000 deaths but are not known if those were due to causes, the progression of a disease or linked to the medicines.

The company has responded by saying that the number of the reports was much smaller than reported by the MHA.