The European Commission, European Medicines Agency and World Health Organization have set-up a cooperation scheme in order to better protect global public health. The new collaborative institution will aim to share information. The focus will be on the safety, quality and efficacy of medicines. The new way of working came into effect last month.
The new arrangement aims to improve lines of communication. In the past health effects in relation to drugs have occurred due to information not being shared effectively.
The arrangement also aims to allow patients to access new medications more quickly; this includes more innovative drug products. This will happen by removing the requirement for each of the agencies to review the same product dossier. This will help to lower the ‘time-to-market’ for new pharmaceutical compounds.
The types of information exchanged will include:
Adverse drug reactions;
Safety concerns
Scientific advice;
Activities of significant public health interest;
Reports from inspections, manufacturing facilities and clinical research activities and related reports.
The information exchanged, however, is classed as “non-public,” which means that members of the public will not be able to review the items listed above.
In related medicinal safety news, European Pharmaceutical Review reports the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MOU) with its counterpart body in India, the Central Drugs Standard Control Organisation (CDSCO). With regard to the U.K. around 25 percent of medicines used in Britain are manufactured in India.
The new agreement is, in part, an attempt to drive up standards with Indian pharmaceutical manufacturers. Digital Journal readers will be aware there have been a number of quality control and assurance concerns relating to medicines imported from India into Europe and to North America. For example, Pan Drugs Limited of Nandesari, India was recently cited by the U.S. FDA for evidence of pigeons inhabiting an area in the company that is used to process medications.
