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Dispatches from AAPS

Peru's GMP requirements mean delayed approvals, says expert

By Gareth Macdonald , 16-Oct-2012
Last updated on 16-Oct-2012 at 10:34 GMT

Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information. 

Peru previously accepted good manufacturing practices (GMP) certificates from a drug manufacturer’s country of origin. However, since 2010 the Ministry of Health has required that products are certified in compliance with Peruvian standards.

This requirement - which saw 70 Chinese manufacturers without Peruvian GMP accreditation banned from exporting to the country last year according to a Business Monitor International report (available for purchase here ) - is extending the time it takes to get market approval in the country.

This was the conclusion set out by Merck & Co regulatory affairs expert Ganapathy Mohan at the American Association of Pharmaceutical Scientists (AAPS) annual meeting in Chicago yesterday during the Q&A session of his talk on approval challenges in emerging markets.

"Peru is heightening their GMP type requirements, but I'm not sure that some of the things we are asked are producing any more value from a review perspective" he said, citing manufacturing data as one area where the country is asking for too much information.

"If you have a data set it is one thing [for regulators] to ask for raw data, that is fine. But if you are asked for multiple signatures for that, from the site at which it was manufactured and the site at which it was tested it becomes extremely onerous."

Turkish example

Mohan also cited Turkey as an example of what can happen when regulators choose to impose stricter GMP requirements on drugmakers.

In 2009 the Turkish Ministry of Health said that in order for a pharmaceutical product to be imported the manufacturer must submit a GMP certificate issued by the ministry or a country with which it has a mutual recognition agreement.

This does not currently include European Union member states as the European Commission explained in a document published earlier this month.

"GMP certificates issued by EU Member States... are still not accepted and the products require a GMP certificate issued by the Turkish authorities. This causes long delays in the registration process and results in de facto discrimination against EU imports to the advantage of domestic producers."

In the same document the Commission said the GMP certificate issue coupled with the requirement that Turkish authorities conduct inspections of drug manufacturing sites before drug approvals can be granted.

Parallel

But while Mohan did draw the Parallel between what's happening in Peru and Turkey, he did inject a note of optimism by suggesting that progress was being made.

"While we went through this learning curve understanding the Turkish requirements [on GMP and inspections], some of the approvals that we have been getting in Turkey have been expedited because they [the regulators] have inspected the sites. It is getting a little better now."

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