Indian Regulators promote two levels of GMP

New Drug Approvals

GMP deviations and even data falsification have been identified in a number of companies in India. How is it possible that interpretation of FDA and EU authorities on one side and the Indian authority on the other side come to a completely different picture? Read more in our GMP News

GMP deviations and even data falsification have been identified in a number of companies in India. The FDA has issued numerous Warning Letters, the EU has published GMP Non Compliance Reports in its EudraGMDP database and EDQM has withdrawn various CEPs because of GMP inspection findings.

In an article published by Regulatory Focus on 28 January 2014 the question has been raised whether Indian companies have a chronic data falsification problem. The article lists 7 companies in India which have received a Warning Letter in the past months – all of them because of GMP deviations and because of “actually…

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Japanese Pharmacopoeia and Japanese GMP Regulations available online

New Drug Approvals

Japanese Pharmacopoeia and Japanese GMP Regulations available online

On Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website, you can download documents on GMP as well as on marketing authorisations for medicinal products. An English version of the Japanese Pharmacopoeia (JP) is also available. You will find the direct links in the News.

On Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website, you can find in the section “Regulations and Procedures” under the heading “GMP” requirements regarding the inspection of manufacturers of medicinal products and APIs who want to introduce their products into Japan.

Now, a document was supplemented in January 2014 which describes which documents have to be submitted to the Japanese Agency within a pre-approval inspection and/ or a periodical post-approval inspection.

Go to the PMDA webpage to get more information.

There, you can also access the current Japanese Pharmacopoeia Sixteenth Edition in English.

Source: PMDA, Japan

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FDA Secure Supply Chain Pilot Program: 13 companies prequalified

New Drug Approvals

FDA Secure Supply Chain Pilot Program: 13 companies prequalified

In August 2013, the FDA initiated the so called Secure Supply Chain Pilot Program (SSCPP) to enhance the security of imported drugs. Now, the first companies have been listed. Read more.

In August 2013, the U.S. Food and Drug Administration (FDA) initiated the so called Secure Supply Chain Pilot Program (SSCPP) to enhance the security of imported drugs.

The goal was to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States.

With this program, FDA wants to better focus its imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

The SSCPP is a voluntary program. Each firm accepted to participate in the program will be allowed to have up to five drugs subject to…

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