Swiss companies to benefit from mutual recognition of GMP

Insight into Korea-Switzerland mutual recognition agreement on GMP

Swiss drugs to reduce approval review period in Korea by three to four months

MRA to put Korea on favorable position for international trading

A mutual recognition agreement of Good Manufacturing Practice (GMP) with Swiss pharmaceutical regulator Swissmedic would not only invigorate pharmaceutical trade between two countries, but also it is expected to be a meaningful step towards Korea earning recognition of international level of regulation.

 

The mutual GMP recognition agreement would bring significant influence on Korea, as Switzerland is one of A7 countries, which the Korean regulators refer to when deciding new drug pricing, and is also a pharmaceutical powerhouse with headquarters of Novartis, Roche and other major global companies.

 

Korea’s Ministry of Food and Drug Safety (MFDS) announced on Dec.

 

18, it would be officially signing a Mutual Recognition Agreement (MRA) of GMP with Swissmedic.

 

When the agreement comes in effect, GMP evaluation when applying for new drug approval in either country would be exempted.

 

GMP certificate from either country would be validated in the other country.

 

As a result, local due diligence, written review and other review procedures would be eliminated and ultimately accelerate the drug approval process.

 

Korean pharmaceutical and bio companies would be able to reduce commercialization preparation period in Switzerland with the mutually recognized GMP certificate.

 

The same goes for Swiss pharmaceutical and bio companies.

 

Their new drug would be exempted from MFDS’ GMP evaluation.

 

Actually, Korea has more drugs importing from Switzerland than exporting to them.

 

Pharmaceutical powerhouse Switzerland houses major global pharmaceutical companies like Novartis and Roche.

 

To this date, MFDS reviewers paid a visit to the local manufacturing plant and conducted GMP due diligence when reviewing Swiss pharmaceutical products.

 

The MRA would drop GMP due diligence and other written review, which would reduce Swiss drug’s approval period in Korea by three to four months.

 

It would be remarkable benefit for Novartis, Roche and other Swiss pharmaceutical companies.

 

Targeting the Korean market, the Swiss companies now have the upper hand against other U.S.

 

or European pharmaceutical companies.

 

Although Korea exports less volume of pharmaceutical products to Switzerland, the intangible value generated from the MRA would shine through for the Korean industry later in the future.

 

Signing of the MRA could mean that such a major pharmaceutical powerhouse recognizes Korea’s regulatory capability.

 

The GMP recognition agreement MFDS signed with Ecuador in 2014 only applies to Korean drugs applying for approval in Ecuador, and it does not apply on Ecuadorian drug in Korea.

 

MRA can only be signed by two countries when their regulatory standards are mutually recognized as equivalent level.

 

Accordingly the signing of the MRA proves Switzerland also thinks highly of Korean regulatory standards.

 

This could be favorable for Korea when negotiating with other countries.

 

MFDS is currently seeking for opportunities to negotiate MRA on GMP with countries that have joined Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/s).

 

Increasing number of countries with high faith in Korean regulatory system would simplify local new drug approval process for Korean-made drugs and also positively influence the industry’s business.

 

MFDS official explained, “As Switzerland is not part of EU, it had an independent regulation apart from EMA and Korean companies had to go through another set of review process.

 

The country is a home of global companies like Roche and Novartis, and CMO companies like Lonza.

 

Korea has been recognizing Switzerland as one of A7 external reference pricing countries with their outstanding review capability that other advanced countries also approve of”.

 

“MRA with Switzerland on GMP would be an opportunity for Korea to raise awareness of Korea’s trustworthy regulatory capability to other countries”, the official added.