Pharmaceutical products require high safety and efficacy standards, which are implemented through pharma regulations. The rules drawn by regulatory bodies guide the activities of Pharmaceutical companies to enforce consistency and global standardization. Therefore, pharmaceutical businesses must operate within acceptable standards. To get approval for your business, you must understand and comply with pharma regulations in different countries.

Photo by National Cancer Institute on UnsplashO

Overview
of pharma regulation bodies

The
primary regulatory bodies in the U.S and Europe – the EMA and FDA have the same
goal. However, some differences make them arrive at different decisions.
Therefore, to get their approval, companies should understand them.

• The FDA is a government regulatory body that controls the manufacture and development of foods and drugs within the United States. This is done on-site by FDA staff, which means that procedures, usually done overseas, for example, clinical trials, must also be supervised and overseen by an FDA staff. Every newly developed drug that is submitted to the FDA is measured against the placebo according to existing regulations.
• Unlike the FDA, the EMA controls operations in more than one country – the EU and European Free Trade Association countries. Therefore, these differences demand a different operational structure. The job of the EMA is mainly to review supervisory works already done by national agencies. Therefore, decision-making differs, and new drugs are measured against existingdrugs.

However,
both regulatory bodies agree that the bulk of ensuring consumer safety is on
Pharma manufacturers. Therefore, they place regulations on every step of the
drug production process. 

Clinical
Trials

Right
after preclinical trials of a new drug, clinical trials begin on humans.
Clinical trials are costly and might take a long time because of the stages
involved. During this process, the regulator carries out checks for safety,
effectiveness, interaction, and dosages. 

For
more understanding of the clinical trial procedure, you can read up insights into the process of drug approval.

Clinical
trials are a critical phase for international companies. While they handle all
technical requirements, they risk losing data in the process of translation and
interpretation. Not only in the laboratory but also in the exchange of
documents between pharma and regulatory bodies, which includes translated
medical terms. 

At the
end of the day, while clinical trials are a challenging phase for all
pharmaceutical businesses. International companies face a unique challenge of
the language barrier in healthcare. The recent clinical trial regulation by the
EMA passed in 2019, mandates a high level of transparency and safety, so
there is no room for error when translating or interpreting research data and
findings.

Pharmaceutical
companies trying to get regulatory approval 

As seen
with the recent pandemic development, a lot of companies have submitted several
drugs that are still awaiting approval.

Despite
it falling under cases to be fast-tracked, we can get a glimpse into how long
and complicated getting approval can be. 

Knowing
these challenges, it is no wonder that a 2019
report by GAO disclosed that for
two years, only 12% of 2030 drug applications submitted passed at first review.
To address this, the FDA decided to improve the clarity of its communication
with applicants. Foreign companies can only take advantage of this with the
adequate translation of all documents involved. 

Clinical
Trials

Right
after preclinical trials of a new drug, clinical trials begin on humans.
Clinical trials are costly and might take a long time because of the stages
involved. During this process, the regulator carries out checks for safety,
effectiveness, interaction, and dosages. 

For
more understanding of the clinical trial procedure, you can read up insights into the process of drug approval.

Clinical
trials are a critical phase for international companies. While they handle all
technical requirements, they risk losing data in the process of translation and
interpretation. Not only in the laboratory but also in the exchange of
documents between pharma and regulatory bodies, which includes translated
medical terms. 

At the
end of the day, while clinical trials are a challenging phase for all
pharmaceutical businesses. International companies face a unique challenge of
the language barrier in healthcare. The recent clinical trial regulation by the
EMA passed in 2019, mandates a high level of transparency and safety, so
there is no room for error when translating or interpreting research data and
findings.

Pharmaceutical
companies trying to get regulatory approval 

As seen
with the recent pandemic development, a lot of companies have submitted several
drugs that are still awaiting approval.

Despite
it falling under cases to be fast-tracked, we can get a glimpse into how long
and complicated getting approval can be. 

Knowing
these challenges, it is no wonder that a 2019
report by GAO disclosed that for
two years, only 12% of 2030 drug applications submitted passed at first review.
To address this, the FDA decided to improve the clarity of its communication
with applicants. Foreign companies can only take advantage of this with the
adequate translation of all documents involved. 

Role of
translation in getting approval for foreign companies 

Foreign
companies that wish to distribute their products within any of these locations
must comply with the regulations. That means they must perform beyond the
limits of language and cultural barriers. To be able to do that, they must
employ professional medical translation services. 

They
are not exempt from the high standards held by regulatory bodies. They must
perform the necessary trials required and give relevant feedback. 

It is
in the process of data exchange and submissions that language barriers must be
managed. Businesses must submit the correct data, and every form of regulation
requires accurate translations. 

Therefore,
pharmaceutical translational services ensure that no data is lost during the
submission process. However, bear in mind that regulations are not static and
are usually changed/reviewed in the face of new challenges and understanding.

What
this means for your business 

Finally,
what do all these mean for your business? 

It
means that Pharma regulations are a costly and sometimes complicated process.
Therefore, every business owner must be prepared and take into consideration
the pharma regulations of the locality they wish to enter. 

Businesses
must also prepare for the trials as well as legal procedures.

This is
sometimes a long process, where mistakes in any form are usually costly.
Therefore, every written and oral communication channel ought to be efficient.
Professional and localized translational services are critical for foreign
companies to make sure that nothing is lost in translation. TranslationsinLondon has
a team of professional translators with top of the line linguistic skills
required for all your pharmaceutical translations needs.