API plant inspections to continue despite rule change say South African regulators

By Gareth Macdonald

- Last updated on GMT

MCC changes API rules to address drug shortages
MCC changes API rules to address drug shortages

Related tags Pharmacology Pharmaceutical drug

South African regulators will continue to inspect all local and some international API sites despite relaxing facility assessment rules last week.

On Wednesday the Medicines Control Council (MCC) said drugmakers seeking approval could submit data from API suppliers it had not inspected if they had been prequalified by the World Health Organisation (WHO).

MCC registrar Joey Gouws confirmed this, telling in-Pharmatechnologist.com the regulator “is accepting the API prequalified by the WHO, however, the [drug] company needs to still apply and needs to submit the applicable CPQ​.”

The MCC will continue inspecting local API manufacturing facilities in line with international best practises as none of the local API sites are prequalified by the WHO​” Gouws continued, adding that “international API sites will be inspected as and when directed by the MCC​.”

Prior to accepting WHO prequalification status, the MCC had inspected the manufacturing site of each API supplier as part of a review process that also saw it assess the finished product and efficacy and safety data provided by the drugmaker seeking approval.

Skipping the inspection step is likely to reduce the time is takes to review drug applications, which is currently around 15 months according to pharmaceutical firms that spoke to the South African press.

Stavros Nicolaou, Aspen Pharma’s head of strategic trade, told BusinessDay​ the MCC’s decision “will make an impact, particularly for high-volume products where limited numbers of active pharmaceutical ingredient suppliers have been registered.”


This is significant as drug shortages are a big problem in South Africa according to the Stop Stock Out Project.

The organization – which was set up by MSF, the RHAP, RuDASA, SA HIV Clinician’s Society, SECTION27 and the TAC – conducts an annual survey of drug availability in the country each year the 2014 version of which was released last week​.

Stop Stock out lists API supply problems encountered by manufacturers as a major factor in current drug shortages.

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