Reduction in medicine registration backlogs

Last week, the Medicine Control Council (MCC) announced plans to reduce the backlogs in the registration of unregistered medicines.

Since the announcement, pharmaceutical firms have warmly welcomed the council’s decision. The National Association of Pharmaceutical Manufacturers (NAPM) said: “The announcement by the MCC Secretariat on their website about a phased plan to reduce the medicine registration backlog is welcomed by the NAPM members and especially the spirit of transparency and cooperation it displays.”

The council have stated that the plan involves two phases, with the aim to complete the first phase by the end of the year (December 2016). Registrar of Medicines at MCC,Dr JC Gouws added: “The first phase of the backlog involves the product in the pre-registration phase.”

Gouws informed us that plans have already been implemented and the steps to be put in place by the industry include, identifying the current market needs for the products in the backlog and putting resources in place to ensure that the dossier under review complies with current regulatory requirements.

He added: “MCC are to ensure that resources are available to scrutinise the quality of the dossier and that evaluators are available to attend to the dossiers under review.”

When enquiring about the beneficial outcomes for pharmaceutical companies, NAPM responded: “We can only speak for generic medicine companies, which make considerable investment in building up the registration dossiers and paying license fees to dossier owners, irrespective of the ability to sell the drugs.”

This will not only benefit generic pharmaceutical companies but consumers too. NAPM said that any new generic medicine registrations should be only of benefit to patients, the reason be that the competition amongst manufacturers will increase which in turn will lead to a reduction in prices.

“A recent survey carried out by the NAPM into the 200 most prescribed medicines shows a 45% difference between the average generic and originator prices and a 56% reduction when the originator is compared with the most affordable generic medicines,” added NAPM.

Therefore, consumers will benefit through an increasing variety range of choices and lower prices, while pharmaceutical companies will find investing in further products less risky.

NAPM concluded: “Recent interactions between the MCC Secretariat and the industry have been encouraging and augur well for the establishment of the new South African Health Products Regulatory Authority, which will supersede the MCC in April next year.”

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