KOREA PHARM & BIO 2027

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Industry trends

Key trends shaping this market and its wider industry.

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Latest updates from across the market.

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A range of accommodation options near the venue and across key areas.

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Frequently asked

Glossary

1

Active Pharmaceutical Ingredient (API)

The biologically active substance in a medicine that produces the intended therapeutic effect. API sourcing, quality qualification, and supply security are central to pharmaceutical manufacturing and are recurring topics in ingredient and CDMO discussions.

2

Excipient

An inactive substance used to carry, stabilize, or help deliver the API in a finished dose form. Excipient selection affects stability, bioavailability, and patient acceptability, and is a regular subject in formulation and sourcing meetings.

3

Good Manufacturing Practice (GMP)

A regulatory system of quality assurance covering premises, equipment, personnel, documentation, and production controls. Korean and international pharmaceutical manufacturers align GMP audits with MFDS, FDA, and EU requirements.

4

Contract Development and Manufacturing Organization (CDMO)

A company that provides outsourced process development, scale-up, and commercial manufacturing for drug substance or drug product. Sponsor companies use CDMOs to add capacity or specialized technologies without building new plants.

5

Bioequivalence (BE)

A regulatory study showing that a test formulation delivers the same rate and extent of absorption as a reference product. BE data support generic drug approvals and are a key topic for formulation and regulatory teams.

6

Common Technical Document (CTD)

A harmonized format for organizing quality, safety, and efficacy information in marketing applications under ICH. Modules 1-5 structure the dossier for regulators in Korea, the US, the EU, and other markets.

7

Drug Master File (DMF)

A confidential submission to a regulator that provides detailed information about facilities, processes, or materials used in manufacturing. It lets suppliers support multiple customers' applications without disclosing proprietary data.

8

Process Validation

Documented evidence that a manufacturing process consistently produces a product meeting predetermined quality attributes. Validation activities span process design, qualification, continued process verification, and change control.

9

Cleanroom Classification (ISO 14644)

A controlled environment with defined airborne particle and microbial limits, classified under standards such as ISO 14644. Aseptic filling, sterile compounding, and certain API handling require qualified cleanrooms with gowning and environmental monitoring.

10

Lyophilization

Freeze-drying that removes water from a formulation by sublimation under vacuum to improve stability. It is common for injectable biologics and other heat-sensitive products, and requires cycle development and scale-up expertise.

11

Fill-Finish

The final manufacturing stage where a sterile or non-sterile product is filled into vials, syringes, cartridges, or other containers and then sealed. Aseptic fill-finish capacity is a major investment area for biologics and injectables.

12

Quality by Design (QbD)

A systematic approach that starts with a defined quality target product profile and uses risk assessment and design space to build quality into the process. Regulators encourage QbD principles in pharmaceutical development and lifecycle management.

13

In Vitro Dissolution Testing

A laboratory test measuring how quickly an oral dosage form releases its API into a dissolution medium. It is used for formulation development, quality control, and demonstrating similarity for generic products.

14

Serialization

A track-and-trace system that assigns unique identifiers to individual saleable units and aggregates them into cases and pallets. Pharmaceutical manufacturers use serialization to meet anti-counterfeiting and supply-chain regulations in Korea and export markets.

15

Pharmacovigilance

The science of detecting, assessing, and preventing adverse effects from medicines. It covers individual case safety reports, signal management, risk management plans, and periodic safety reports.

16

Ministry of Food and Drug Safety (MFDS)

Korea's Ministry of Food and Drug Safety regulates pharmaceuticals, medical devices, and food. Companies launching in Korea interact with MFDS for product approvals, GMP inspections, and clinical trial oversight.