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.

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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.