Drug Approval

Authorization is a procedure in which the Ministry of Food and Drug Safety actively judges suitability through review, whereas notification is a procedure handled mainly through confirmation of formal requirements when certain conditions are met.

However, the fact that something is a notification does not mean that responsibility is reduced, and a false or deficient notification is equally subject to administrative disposition.

Approval and reporting are conducted on an item-by-item basis.

Even with the same ingredient, a separate approval or report may be required depending on the dosage form, dosage and administration, efficacy and effect, and excipient composition.

For this reason, a review of the approval strategy is necessary when making development changes or expanding a lineup.

Clinical trials, nonclinical data, the active pharmaceutical ingredient (DMF), the manufacturing method, and quality data are reviewed collectively at the approval stage.

If the approval requirements are not considered at the early development stage, this may lead to a delay in approval or a return of the application even after the clinical trials are completed.

The subjects of notification are a group of pharmaceuticals whose safety and efficacy have already been relatively well established.

Representative examples include the following cases.

However, even if similar to an existing item, a pharmaceutical may be excluded from the subjects of notification where it uses an additive with no record of domestic use or where the particularity of its dosage form is recognized.

The subjects of approval are medicines requiring a substantive review of safety and efficacy.

In such cases, the submission of advanced data is required, including clinical data, comparative data, and impurity and genotoxicity assessments.

Some matters subject to approval are handled by a regional office of the Ministry of Food and Drug Safety, while some are reviewed by the Ministry's headquarters.

Because the review procedure and response strategy may differ depending on jurisdiction, advance assessment is necessary.

Where changes to efficacy and effect, dosage and administration, or formulation are anticipated during the drug development process, it is important to confirm the position of the Ministry of Food and Drug Safety in advance through a preliminary review.

This is a key means of reducing the risk of approval rejection.

Pharmaceutical approval proceeds through the following steps.

A request for supplementation may arise at each stage, and a delay in response can delay the entire schedule.

Drugs subject to approval must submit the data in the CTD (Common Technical Document) format, and the logical structure and the consistency among the data have a significant effect on the review result.

Simply translating overseas approval data can be a cause of delay in the review.

A change approval and a change notification are distinguished according to whether the change affects safety, efficacy, or quality.

A change that has a material effect on safety, efficacy, or quality is subject to change approval, and a relatively minor matter is handled by change notification.

However, even for a matter subject to change notification, if the requirements are misjudged, it may be found that a matter subject to change approval was handled by notification alone, which can become a problem, so prior review before the change is important.

The following changes are, in principle, subject to change approval.

In particular, a change to efficacy and effect or to the manufacturing method requires the submission of additional data and may, in some cases, lead to a reassessment of safety and efficacy.

A minor change that does not affect quality may be subject to change notification or annual reporting.

For example, certain container or packaging changes that do not affect stability and minor corrections of stated information may be subject to annual reporting.

However, where a change affects quality, such as a change to the primary container, even if it appears minor in form, it is subject to change approval, so a specific review is necessary.

Even where the status of a manufacturer or importer changes through transfer, acquisition, merger, inheritance, or the like, a change in license or a report of change must be made for each item.

In this case, the change procedure is carried out on the condition of succeeding to the existing license and reported matters, and the documents to be submitted and the competent authority may differ depending on whether the business name, location, or representative changes.

A change in approval or a change report is easily mistaken for being simpler than the initial approval, but in practice review delays frequently occur due to errors in judging the scope of the change, omission of materials, mistakes regarding the competent authority, and the like.

Accordingly, systematic management is necessary.

If the distinction between approval and notification, the question of whether a matter is subject to safety and efficacy review, and the assessment of the scope of materials to be submitted go wrong from the outset, this can lead to approval delays, repeated supplementation, and changes to the business schedule even after clinical trials are completed.

In particular, because pharmaceutical and bio companies must consider the following factors together, this can be regarded as an area that requires specialized interpretation of law and regulation.

Daeryun includes among its members medical attorneys with experience working at pharmaceutical companies and pharmacist qualifications, as well as professionals with expertise in the regulatory and administrative fields.

From the design of the approval type at the early development stage to clinical strategy, the assessment of product approval and notification, change approval, and post-management, it provides practical assistance linked to the business schedules of pharmaceutical and bio companies.

If you are in a situation that requires related legal advice, please feel free to request assistance from a 🔗medical attorney at any time.