When Literal Translation Distorts Legal Meaning: A Pharmaceutical Regulatory Translation Case Study

In legal and pharmaceutical translation, a phrase that appears straightforward may carry a highly specialized meaning. Translating such terminology word for word can produce a target text that is grammatically acceptable but conceptually inaccurate.

I encountered one such example while editing an English-to-Indonesian translation of a legal-pharmaceutical document for a pharmaceutical company.

The source text contained the following phrase:

Source:
Regulatory submissions and compliance

The translator rendered it as:

Initial translation:
Pengajuan regulasi dan kepatuhan

As the editor, I revised it to:

Edited translation:
Penyerahan data lengkap kepada lembaga pengawas dan kepatuhan pada peraturan

The difference may appear minor, but it involves two important issues: the specialized meaning of regulatory submissions and the grammatical and semantic scope of regulatory in the coordinated phrase.

1. Why “Regulatory Submissions” Does Not Mean “Pengajuan Regulasi”

The first problem lies in translating regulatory submissions as pengajuan regulasi.

Taken literally, the Indonesian phrase pengajuan regulasi can suggest that the pharmaceutical company is submitting or proposing a regulation. That interpretation does not accurately reflect the company's role in the regulatory process.

A pharmaceutical company does not ordinarily submit regulations for enactment. Rather, it submits scientific information, documentation, and supporting data to the competent regulatory authority as part of a regulatory review or approval process.

According to PharmaSource, regulatory submissions are comprehensive packages of scientific information and data submitted to regulatory agencies to demonstrate that a healthcare product is safe, effective, and manufactured to the required quality standards.

This definition is important because it clarifies the relationship between the two elements of the term.

In regulatory submissions, the word regulatory does not identify the object being submitted. It identifies the regulatory context and, more specifically, the involvement of a regulatory authority.

The actual object of the submission is the relevant documentation, information, and data.

Accordingly:

regulatory submissions
does not mean
submission of regulations

but rather:

submission of information and data to regulatory authorities

For this particular document, I therefore rendered the term as:

Penyerahan data lengkap kepada lembaga pengawas

This wording makes the intended relationship explicit: the pharmaceutical company provides the relevant data to a regulatory authority, such as Indonesia's BPOM or the U.S. Food and Drug Administration.

The example illustrates an important principle of specialized translation: terminology must be interpreted as a unit within its professional context, rather than as a sequence of individual dictionary equivalents.

2. The Scope of “Regulatory” in “Regulatory Submissions and Compliance”

The second issue concerns the word compliance.

The translator rendered the source phrase as:

Pengajuan regulasi dan kepatuhan

Here, compliance was translated simply as kepatuhan. Although kepatuhan is a valid general equivalent of compliance, the translation leaves an important question unanswered:

Compliance with what?

The intended meaning can be understood from both the grammatical structure and the pharmaceutical regulatory context.

The phrase:

regulatory submissions and compliance

can be interpreted as a coordinated construction in which regulatory has semantic scope over both submissions and compliance.

In expanded form, the phrase may be understood as:

regulatory submissions and regulatory compliance

English frequently avoids unnecessary repetition when the intended modifier can be recovered from the grammatical structure and context.

In this case, therefore, compliance should not be interpreted in isolation. The intended meaning is regulatory compliance—compliance with the applicable regulations, regulatory requirements, or legally binding standards governing the pharmaceutical company's activities.

For that reason, I translated the second element as:

kepatuhan pada peraturan

rather than simply:

kepatuhan

The additional wording makes explicit in Indonesian what is implicit in the English source.

3. Why Context Matters More Than Word-Level Equivalence

This case demonstrates why specialized legal and pharmaceutical translation cannot be approached as a mechanical replacement of English words with their most obvious Indonesian equivalents.

At the lexical level:

• regulatory may suggest regulasi;

• submission may suggest pengajuan or penyerahan; and

• compliance may suggest kepatuhan.

However, translation decisions must be made at the level of meaning, function, grammatical relationship, and domain-specific usage.

The translator must determine:

• what is actually being submitted;

• to whom it is being submitted;

• why it is being submitted;

• what regulatory function the submission performs; and

• what type of compliance is intended.

Once these questions are considered, pengajuan regulasi dan kepatuhan becomes problematic.

First, pengajuan regulasi may incorrectly imply that regulations themselves are being proposed or submitted by the pharmaceutical company.

Second, kepatuhan by itself does not communicate the regulatory framework to which the company must adhere.

The edited version:

Penyerahan data lengkap kepada lembaga pengawas dan kepatuhan pada peraturan

makes both relationships explicit and preserves the intended regulatory meaning more accurately.

4. The Editor’s Role in Specialized Legal-Pharmaceutical Translation

This example also illustrates why editing specialized translations involves considerably more than correcting grammar, spelling, punctuation, or stylistic inconsistencies.

A sentence may be grammatically correct while still being terminologically or conceptually wrong.

In highly regulated industries such as pharmaceuticals, an editor must therefore examine several layers simultaneously.

Terminological accuracy

Does the target-language expression convey the specialized meaning of the term as used in the relevant industry?

Contextual accuracy

Does the translation correctly reflect the relationship between the pharmaceutical company, the regulatory authority, the documents being submitted, and the applicable regulatory framework?

Grammatical interpretation

Has the translator correctly identified modification, coordination, ellipsis, and other syntactic relationships that may affect meaning?

Regulatory logic

Does the translation accurately represent what the organization is legally, procedurally, or institutionally expected to do?

In this case, understanding the institutional relationship was decisive.

The pharmaceutical company submits information and data to a regulatory authority and operates in compliance with applicable regulations.

It does not “submit regulations.”

5. A Small Phrase, a Significant Difference

The source phrase consisted of only four words:

Regulatory submissions and compliance

Yet translating those four words accurately required considerably more than selecting four dictionary equivalents.

It required an understanding of pharmaceutical regulatory processes, careful analysis of English grammatical structure, terminological research, and consideration of how the resulting Indonesian expression would be understood by its intended readers.

That is precisely where specialized legal translation differs from literal translation.

The objective is not merely to reproduce the words of the source text.

It is to reproduce, as accurately as possible, the legal, regulatory, and professional meaning those words carry in their actual context.

References

1. PharmaSource. “Pharmaceutical Regulatory Submissions: A Comprehensive Guide for Industry Professionals.”
   https://pharmasource.global/content/guides/category-guide/pharmaceutical-regulatory-submissions-a-comprehensive-guide-for-industry-professionals

2. PharmaSource. “Pharmaceutical Regulatory Authorities: An Overview.”
   https://pharmasource.global/content/guides/category-guide/pharmaceutical-regulatory-authorities-an-overview/