Pharmaceutical products

Pharmaceutical products (의약품/醫藥品) are referred to as a medicine or broadly medical devices.

Pharmaceutical drugs are defined as any chemical substance, or product comprising such stuff, intended for use in the medical diagnosis, cure, treatment, or prevention of disease.

In Korea, pharmaceutical products are generally regulated by the Pharmaceutical Affairs Act (the "PA Act" 약사법/藥事法) and medical devices by the Medical Devices Act (the "MD Act" 의료기기법/醫療器機法) in terms of their manufacture, importation, distribution and advertisement. The pricing of pharmaceutical products and medical devices is governed by the National Health Insurance Act (the "NHI Act" 국민건강보험법/) and other applicable laws and regulations.

The Ministry of Food and Drug Safety (MFDS 식품의약품안전처/食品醫藥廳) has the authority to enforce the PA Act and the MD Act, while the Ministry of Health and Welfare (MOHW 보건복지부/保健福祉部) may enforce the PA Act, the MD Act and the NHI Act. Competition issues arising out of the pharmaceutical and medical device sector are regulated by the Korea Fair Trade Commission (KFTC 공정거래위원회/公正去來委員會).

Key words
pharmaceutical affairs, pharmaceutical products, medicine, medical device, clinical trial

Classification
The regulatory regime in Korea adopts the following classification of products in the pharmaceutical sector and medical device sector.

Pharmaceutical products
The governing law is the PA Act and it defines pharmaceutical products as:
 * products that are not identified as quasi-pharmaceutical products in the substances list issued by the Korean pharmacopoeia;
 * any substance used for the purposes of diagnosing, curing, mitigating, treating or preventing human or animal diseases; and
 * any substance (other than instruments, apparatuses or cosmetics) used by humans or in animals to exert pharmacological actions.

Traditional herbal pharmaceutical products (that are not simple herbs) qualify as pharmaceutical products under the PA Act. Simple herbs are deemed to be food products and are regulated by the Food Sanitation Act (식품위생법/食品衛生法).

Quasi-pharmaceutical products
Among the following types of products, only those that are officially designated by the MOHW will be recognised as quasipharmaceutical products: The governing law is the PA Act.
 * any fibre or rubber products that are used for medical treatment, but are not administered to human bodies;
 * products (other than instruments, apparatuses, appliances or other articles) that minimally affect body functions; and
 * germicides or insecticides used for the prevention of epidemics.

Functional foods
Functional foods (기능성식품) are defined as processed food containing health-promoting compounds or ingredients. The Health Functional Foods Act (건강기능식품에 관한 법률/健康機能食品法) is the governing legislation.

Medical devices
These are instruments, apparatuses, appliances or other articles (excluding pharmaceutical products or quasi-pharmaceutical products) used to: The MD Act is the governing legislation.
 * treat diseases;
 * diagnose, treat, alleviate or cure injuries or physical disabilities;
 * examine, replace or modify the anatomy or the function of the human body; or
 * control conception.

Cosmetics
Substances intended to be applied to the skin for cleansing or beautifying, or applied to the skin or hair to maintain or enhance its condition, but which have minimal effects on body functions, are classified as cosmetics.

They are governed by the Cosmetics Act (화장품법/化粧品法).

The Supreme Court has held that all substances recognised by or represented to the public to:
 * diagnose, cure, mitigate, treat or prevent diseases in humans or animals; or
 * exert a pharmacological action in humans or animals (except for those that can be instantly recognised as food products based on the circumstances), fall under the category of pharmaceutical products regardless of whether such recognition or representation is actually true.

Non-clinical studies
An investigator needs to be designated by the MFDS for non-clinical studies to be conducted. For an institution to qualify as the designated investigator, it must satisfy certain requirements in terms of personnel, facilities and equipment. All non-clinical studies must comply with the guidelines of the good laboratory practice (GLP) issued by the MFDS. Other than the clause requiring humanitarian disposal of diseased laboratory animals, there are no other specific requirements under the guidelines of the GLP on animal welfare.

Clinical trials
There are no qualifications imposed on a sponsor (the sponsor often hires a contract research organisation to administer the clinical trial), but the organisation investigating clinical trials must be a qualified general hospital, a specialised hospital or another institution designated by the MFDS. The institution conducting clinical trials must submit a study protocol, an outline of the methods for recruiting subjects (including advertisements), consent forms to be received from recruited subjects and the data collection forms to its internal institutional review board for review.

The clinical trials must be conducted in accordance with the standards under the Enforcement Rules of the PA Act (which is the good clinical practice of Korea) regarding various factors, such as the test methods, qualifications of the testing institution and testing supervisor, safety plan, test period and preservation of relevant data. To enable the human subjects to give informed consent and to ensure that they do so, the details of the clinical trial, the potential adverse effects on health, and the compensation amount and method must be explained in advance.

Korean laws and regulations are silent on the matters of the payment amount and method for ompensation. The MFDS appears to be considering providing guidelines on the payment amount and methods of compensation soon.

There are no special rules on investigator-initiated studies.

Named-patient and compassionate use procedures
Pre-launch use, as an exception to the rule that requires medicine to be authorised prior to its use, is permitted in the following circumstances, among others:
 * when the Korea Orphan Drug Center (KODC 한국희귀의약품센터), a regulatory authority that governs named-patient supply and compassionate use of medicines, directly imports certain products into Korea;
 * when the MFDS determines that certain products are urgently needed for the treatment of patients; or
 * when the MFDS announces that certain products are necessary for self-treatment or self-aid.

If necessary, a patient may request that the KODC directly import certain products (as in a above) by submitting certain required documents, such as written prescriptions or diagnoses. Any cases of adverse reactions during the pre-launch use of products must be reported to the Korea Institute of Drug Safety and Risk Management.

General procedures
For medicines manufactured in or imported into Korea, each product must have marketing approval from the Commissioner of the MFDS (product approval) for its commercial distribution. For products manufactured in Korea, it is the manufacturer with the intent to distribute the manufactured products that must obtain product approval for the products’ manufacture and sale. For products imported into Korea, it is the importer that must obtain an approval for importation. In its review for product approvals, the MFDS mainly considers whether the factors of safety, efficacy and quality have been satisfied.

Special procedures for follow-on products
Certain generic and biosimilar pharmaceutical products are exempt from safety and efficacy evaluations, but their data on biological equivalency must still be submitted to the MFDS.

Special procedures for accelerated approval of products for unmet medical needs
Orphan drugs are exempt from the submission requirement of information or materials relating to manufacture, quality standards and test methods. Other drugs for the treatment of certain lethal diseases (e.g., AIDS, cancer) or incurable diseases are also temporarily exempt from this requirement.

Fees
Fees range from 27,000 won to 4.14 million won, depending on whether the filing is an application for approval or a report; the safety and efficacy evaluations are required; or the evaluations on data for medical product equivalency tests are required.

Requirements for sponsor location
Product approval must be acquired and held by an entity with an address in Korea.

Requirements for appointment of a local agent are that a local agent does not need to be appointed. However, due to the address requirement imposed on the sponsor, it is common practice for manufacturers based outside Korea to appoint and authorise a local entity to acquire and hold a product approval on its behalf.

General procedures
These are basically the same as those for medicines. However, for certain medical devices with low risk, the manufacturer or importer will not be required to obtain product approval for each and every product. Instead, a blanket approval for the relevant product category will suffice.

Special procedures for follow-on products
Certain follow-on medical devices are exempt from the submission of an application dossier (this is concluded based on the fact that similar follow-on medical devices were approved for exemption in at least three occurrences).

Special procedures for accelerated approval of products for unmet medical needs
Certain state-of-the-art and rare devices, as determined by the MFDS, are exempt from the submission requirement of information or materials relating to clinical trials.

Fees
Fees range from 35,000 won to 447,000 won, depending on whether the filing is an application for approval or a report; the evaluations on data for clinical trials are required.

The requirements for the sponsor’s location and the appointment of a local agent are by and large the same as those for medicines.

Regulatory incentives
Due to the recent introduction of the product approval patent linkage system, it is believed that patent protection for original pharmaceutical products in Korea was heightened as a result. In March 2012, the PA Act was amended to adopt a link between the drug approval system and the drug patent system. Under the amended system, if a party that has obtained product approval on a new drug wishes its information to be placed on the patent list, the party must request the MFDS to do so within 30 days of product approval.

Thereafter, once a generic manufacturer submits an application for generic drug approval, the generic manufacturer must notify the relevant patent holder with a detailed statement demonstrating that the listed patent is invalid or the generic manufacturer’s product does not infringe the patent (this only applies to generic manufacturers that seek product approval for the launching of a product during the term of the listed patent and does not apply to generic manufacturers that intend and indicate that the product will be launched after the listed patent has expired).

The patent holder may file a legal action against the generic manufacturer if the patent holder believes that the generic drug infringes its patent. The generic product approval will be put on hold upon the filing of a legal action. Consumer protection groups in Korea have criticised the new system on the basis that it unduly facilitates the ‘evergreening’ of patents, and as a result discourages generic manufacturers from developing their own products.

Post-approval controls
The product approval holder must appoint at least one person responsible for pharmacovigilance or device vigilance (there are no infrastructure requirements required for post-approval controls) to undertake post-marketing surveillance activities, such as post-approval testing and adverse reaction reporting. If any matter that was reported to the MFDS in the product approval process was altered or modified, the product approval holder must apply for an amendment of the product approval (for cases of the replacement of the product approval holder from the transfer of ownership of the product approval through a private transaction, an amendment must be made within one month from the date of the replacement of the product approval holder).

Product approval will be valid for five years (this validity period of five years took effect on January 1, 2013) and the product approval holder must apply for reissuance of the approval no later than six months prior to the expiration 1date of the validity period.