Points to Consider for Pharmaceutical and Medical Device Regulatory Applications and Selection of Translation Service Providers

1. What is a pharmaceutical application? Why is translation necessary for pharmaceutical applications?

1-1. What is a Pharmaceutical Application?

A drug application refers to the formal application submitted to regulatory authorities (such as the Ministry of Health, Labour and Welfare and PMDA in Japan) in order to release pharmaceuticals and medical devices to the market.
The drug application document for pharmaceuticals includes data on the safety, efficacy, and quality of the drug obtained through clinical trials, based on which regulatory authorities determine whether to approve the new drug or not.

On the other hand, the application for medical devices also aims to submit documents to regulatory authorities based on collected data in order to obtain approval for manufacturing and sales, but the required documents and review content are different from those for pharmaceuticals.

2. Pharmaceutical and Medical Device Regulatory Submission Documents

2-1. Pharmaceutical Regulatory Submission Documents

In the application for pharmaceuticals, test data is necessary to evaluate the pharmacokinetics, toxicity, safety, and efficacy of the drug in detail.
Additionally, documents and clinical trial reports regarding the safety, efficacy, and quality of the pharmaceuticals obtained through clinical trials are also required.

In addition, in the application for approval of pharmaceuticals, it was agreed upon by ICH in 2000 to create documents such as quality, non-clinical trial results, and clinical trial results using the common format (CTD: Common Technical Document) used worldwide. In Japan, the application of CTD was made mandatory in 2003.
This is intended to efficiently and quickly carry out preparations and procedures for approval, and to achieve early release of new drugs.

2-2. Medical Device Regulatory Submission Documents

On the other hand, in the pharmaceutical application for medical devices, detailed documents related to risk management, design and development, and manufacturing processes are particularly important.
In medical devices, each device is classified (Class I, II, III, IV) according to the level of risk, and documents related to risk analysis and risk management are created accordingly.

In addition, technical documents (product specifications, test results, manufacturing methods, quality management systems, etc.) will also be prepared and submitted.

3. Difficulty and Efficient Methods for Translating Pharmaceutical Application Documents

3-1. Difficulty of Translating Pharmaceutical Application Documents

In a previous blog post, we introduced "The Importance of Medical Translation and Pharmaceutical Translation" and discussed the difficulties and important points to note in medical translation.

There,
●It is necessary to have documents that comply with strict regulations in each country for the international introduction of pharmaceuticals and medical devices.
●There is a need to quickly and accurately translate highly specialized information in the medical field, etc.
We have introduced these things. These also apply to the difficulty of translating regulatory submission documents, so we hope you will take a look at them.

[Related Blogs] What is Medical and Pharmaceutical Translation? Reasons Why Translation is Difficult and Points to Consider When Choosing a Translation Service

In addition, we also introduced the importance of quick response in international joint clinical trials on our blog below. Please take a look.

[Related Blogs] What is Localization in Translation? Explaining the Connection with Medical Translation!

3-2. Efficient Methods for Translating Pharmaceutical Application Documents

In pharmaceutical application business, it is crucial to accurately and promptly translate highly technical documents, and to proceed with precision and efficiency.

To achieve this,
●Utilize translators with extensive knowledge and experience in the medical field and pharmaceutical application documents
●Efficiency, speed, and a thorough checking system are crucial, and can be achieved through the use of technology such as machine translation and translation support tools
These are essential factors.

[Related Blogs] How to streamline the translation of clinical trial summary reports?

3-3. Leave the translation of pharmaceutical application documents to Human Science.

In many cases, the translation of pharmaceutical application documents will require consideration of requesting a medical translation company.
However, the selection of a translation company must be done carefully.

Human Science has the following requirements for translating pharmaceutical application documents:
● A company with highly specialized knowledge and experienced translators in the medical field
● A company with a wealth of experience in translating pharmaceutical applications and clinical trials
● A company that can provide solutions with technology

At Human Science, we offer medical translation services such as pharmaceutical application documents for our clients.
We have accumulated experience and expertise in translation support tools, machine translation, and checking tools, and have handled numerous translation and document creation projects. We can provide fast and high-quality translations through the combination of human and technology.
If you are interested, please feel free to contact us.

Pharmaceutical and Medical Translation Services
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