Product Approval

Product approval and product notification are both procedures for distributing pharmaceuticals, but they differ in their scope of application and depth of review.

Product approval can be understood as “approval through verification,” while product notification can be understood as “confirmation of compliance with standards.”

(In certain exceptional cases, however, such as investigational pharmaceuticals and orphan drugs, import may be permitted without product approval.)

The actual procedure takes concrete shape through the following subordinate regulations.

The line between pharmaceuticals subject to product approval and those subject to notification is drawn under the “Pharmaceutical Affairs Act” and the “Regulations on the Product Approval, Notification, and Review of Pharmaceuticals,” and the key criterion is “whether a new risk exists.”

A new drug or a pharmaceutical containing a new active ingredient must obtain approval, because its effect on the human body has not yet been sufficiently verified.

In such a case, the applicant must submit data capable of establishing safety and efficacy, such as clinical trial data and toxicity test data, and the Ministry of Food and Drug Safety conducts a substantive review based on that data.

By contrast, a pharmaceutical already listed in an official compendium (such as the Korean Pharmacopoeia), or one whose ingredients and formulation are standardized, may be classified as subject to notification.

In those cases, the review centers on whether the standards are met, without a separate submission of clinical data.

Pharmaceuticals may look like a single category, but they are in fact subdivided into finished pharmaceuticals, active pharmaceutical ingredients, orphan drugs, and the like, each subject to a different regulatory framework.

First, a finished pharmaceutical is the final product administered directly to the patient, and it faces the strictest review.

Safety, efficacy, and quality data are all required, and clinical trial data carry great weight.

An active pharmaceutical ingredient, by contrast, is a component used to manufacture a finished pharmaceutical, so the consistency of its quality and manufacturing process becomes the key review factor.

Here, the verification centers mainly on quality data and manufacturing standards.

An orphan drug often applies to a very small number of patients and frequently has no alternative pharmaceutical, so requiring data at the same level as for ordinary pharmaceuticals may be impractical.

For that reason, the data submission may be eased within a certain scope, or conditional approval may be granted.

To head off the possibility of harm in advance, the statutes governing product approval restrict approval in certain cases.

The “Regulations on the Safety of Pharmaceuticals, etc.” are representative, restricting product approval in the following situations.

(*e.g., stimulants, excitants, raw materials carrying a risk of infection, etc.)

• Where the product contains an ingredient or dosage form that carries a risk of misuse or abuse

• Where the product is recognized as identical to a product whose existing approval has been revoked

• Where a name that may mislead or confuse the public is used
Regulation of the product name matters as well. Where a name directly states the efficacy or effect, or where an exaggerated name is used, approval may be restricted.

At the initial application stage, the formal requirements are reviewed, and at the subsequent full-scale review stage, the safety, efficacy, and quality are evaluated on the merits.

This process may repeat in response to requests for supplementation, and the total time required can vary considerably depending on the number and content of those supplementations.

The Ministry of Food and Drug Safety reviews the submitted data and, where the scientific basis is insufficient or the data are not internally consistent, requests supplementation.

This supplementation process often calls for substantive additions to the data, such as the further submission of clinical data or the modification of test methods.

During the review, factors such as comparison with pharmaceuticals containing the same ingredient, existing approval precedents, and international standards are also weighed together, and whether to grant approval is decided through a comprehensive review.

For certain pharmaceuticals, where a public-interest need is recognized, conditional approval may be granted.

This applies to situations such as pharmaceuticals for treating serious diseases or cases in which there is no alternative therapeutic agent, and approval is granted on the premise that certain data will be supplemented afterward.

Because conditional approval is an exceptional mechanism, caution is required: a failure to fulfill the later obligation to submit data may trigger additional regulation, such as revocation of approval.

The data required for product approval fall broadly into safety, efficacy, and quality data.

Submission of such data is mandatory under the statute, and imported pharmaceuticals must meet the same level of data submission.

In practice, the data described above are organized and submitted in the CTD (Common Technical Document) format.

The CTD is an internationally accepted standard for pharmaceutical approval data, in which the structure of the data and the method of submission are arranged systematically.

Using this system lets the review agency examine the data under consistent standards, and it also aligns the submission with global approval procedures.

As a result, not only the content of the data but also the way it is organized functions as an important factor in the approval review.

Daeryun Law Firm advises on every stage of the pharmaceutical product approval process, from review of the data to be submitted to the development of strategies for responding to supplementation.

It reviews the legal issues surrounding the safety and efficacy data that become points of contention during the review, and it shapes the direction of the response to requests for supplementation, with a focus on supporting the likelihood of approval.

Where a refusal or revocation of approval has occurred, the firm reviews whether the grounds for the disposition are unlawful and pursues a response through administrative adjudication and administrative litigation, and where necessary, it also reviews the possibility that criminal liability may arise.

If you face a situation that calls for an actual response to the review or to a disposition connected with product approval, you can review specific response measures through the 🔗Medical Attorney Legal Consultation.