Importing Medicines into Japan, South Korea, Australia and New Zealand: A Country-by-Country Guide (2026)

Last updated: 8 October 2026. Part of our region-by-region import guide series. Covers Japan, South Korea, Australia and New Zealand, with a pointer for China.

In Japan, South Korea, Australia and New Zealand, the hard part isn't finding an importer. It's getting approved. All four want a local company to hold the approval and answer for the product. Australia and New Zealand make it much quicker if trusted overseas regulators have already approved your product. Japan and Korea run their own full reviews and check foreign plants and API makers closely. Pricing then decides whether the approval pays off: Japan's NHI price list, Korea's new generic price rules, Australia's PBS and New Zealand's Pharmac tenders.

This guide walks through each market in plain language:

• Japan: MHLW and PMDA, the marketing authorisation holder, foreign manufacturer accreditation, the master file system and NHI pricing.
• South Korea: MFDS, the importer's licence, overseas site registration, DMFs and the August 2026 generic price cut.
• Australia: TGA, the sponsor and the ARTG, the comparable overseas regulator routes, GMP clearance and special access.
• New Zealand: Medsafe, the new verification pathway, section 29 and Pharmac.
• China has its own guide: see NMPA explained.

It's written for manufacturers exporting to the region in India, China, Europe, the US and elsewhere in Asia, and for the local sponsors, importers and distributors who work with them.

How the region works

The same doors exist here as elsewhere: full registration, a faster route built on overseas approvals, public funding or tenders, and special access for an unapproved medicine a patient needs. But the balance is different. These are mature regulators, so the approval itself is the main job. A few features shape all four markets:

• A local holder is always required. Japan needs a licensed marketing authorisation holder, or a designated one for a foreign approval holder. Korea needs a licensed importer. Australia and New Zealand need a local sponsor.
• Reliance splits the region in two. Australia has legislated report-based routes using approvals from seven comparable overseas regulators. New Zealand has an abbreviated route and, since July 2026, a verification pathway built on two recognised approvals. Japan and Korea review in full. Overseas approval helps there, but it doesn't replace local review.
• Plants are checked before approval. Japan accredits foreign manufacturers and inspects for GMP compliance. Korea makes importers register every overseas site, including API sites, and inspects on site. Australia needs GMP clearance for each overseas site. New Zealand needs current GMP evidence from a recognised authority.
• All four are PIC/S members. Australia joined the PIC Scheme in 1995, New Zealand in 2013, and Japan and Korea in July 2014. A PIC/S or EU-GMP certificate is the most useful GMP evidence you can bring.
• API files matter. Japan's master file needs an in-country caretaker. Korea's DMF registration feeds into generic pricing. Our guide to CEP vs DMF vs ASMF explains the differences.
• Dossiers follow the ICH CTD, with a local Module 1, and Japan wants the application in Japanese. See CTD vs ACTD if you're converting a dossier built for Southeast Asia.

The four markets at a glance

Japan

• Regulator: the Ministry of Health, Labour and Welfare (MHLW) grants approvals. The Pharmaceuticals and Medical Devices Agency (PMDA) runs the scientific review, consultations and GMP inspections.
• Who can hold an approval: the company that puts a medicine on the market needs a marketing business licence from the prefecture and a product approval. An importer must hold that licence and the approval, and its foreign supplier must be accredited. A foreign company can hold the approval itself under the foreign exceptional approval route. But it must appoint a designated marketing authorisation holder in Japan, which handles safety reporting and works closely with it.
• Language: PMDA doesn't accept applications in other languages. Application forms must be in Japanese.
• Foreign manufacturer accreditation: every overseas plant making medicines or APIs for export to Japan must be accredited by the Minister, site by site. The foreign manufacturer is the applicant, though its Japanese marketing authorisation holder can file for it. PMDA estimates about five months for processing. Accreditation lasts five years and lapses if not renewed in time.
• Master files: API makers can register a master file (MF) with PMDA to keep their process data confidential from the applicant. A foreign maker can't apply directly and must appoint an in-country caretaker. PMDA doesn't review an MF on its own: it reviews it with the product application that cites it. So the applicant, the MF holder and the caretaker need to work closely together when questions come.
• Generics: a generic needs equivalent quality and bioequivalence with the original product. The re-examination period must have ended and no substance patent may still apply. MHLW also lists stability, specification and impurity data. Our guide to ICH stability guidelines covers the storage conditions.
• Biosimilars: a 2020 guideline sets the quality, safety and efficacy rules, with Q&As added in January 2024 and May 2026. PMDA published early-consideration papers on Japanese comparability data in September 2025 and on when comparative efficacy studies are needed in May 2026. So check the latest thinking before you plan a clinical programme.
• GMP inspections: PMDA checks GMP compliance at approval, on major changes and about every five years afterwards. It also runs risk-based and for-cause inspections. On-site inspection is the standard. PMDA can choose a desk review based on the product's risk and the strength of the exporting country's GMP system. Plants in MRA or MOU countries can submit their own regulator's certificate. Others can use a WHO-format certificate or a certificate from their authority.
• Drug lag and drug loss: Japan worries about "drug loss": medicines approved elsewhere that no one plans to develop in Japan. In March 2023, 143 products approved in the US or EU had no Japanese approval, and 86 of those had no development under way. The response so far:
  • No automatic Japanese Phase 1. Since December 2023, a separate Japanese Phase 1 is generally not needed before joining a multi-regional trial, as long as safety for Japanese participants can be justified.
  • Help for overseas firms. PMDA opened a Washington, D.C. office in November 2024 to advise start-ups in English. MEDISO and the PMDA office offer free English consultations.
  • Pricing reward. A "rapid introduction" premium in the 2024 NHI price rules rewards new drugs filed in Japan at the same time as, or before, the US or EU.
  • Law change. The PMD Act amendment enacted on 14 May 2025 targets quality, supply stability, R&D and pharmacy roles, and makes paediatric development a "duty to endeavour".
• NHI price listing: reimbursed prescription medicines are priced on the National Health Insurance (NHI) price list. New drugs are, in principle, listed within 60 days of approval and within 90 days at the latest. Generics are listed twice a year. A new generic is usually priced at half the original product's price, and lower when many brands of an oral drug enter. Biosimilars start at 70%. Prices are then revised regularly, based on surveys of actual sale prices.
• Without approval: unapproved medicines can't be sold. Personal and patient imports need an import confirmation from MHLW's regional health bureaus.
• Watch out for: the MAH's quality and safety teams carry the legal risk in Japan, so expect close scrutiny of your quality systems. Budget for translation and for questions on your MF during review.

South Korea

• Regulator: the Ministry of Food and Drug Safety (MFDS). In October 2023 it became one of the first three WHO-listed authorities, alongside Singapore and Switzerland.
• Who can register: only a company with an MFDS import business licence can import medicines. The licence needs storage and quality-testing facilities, named managers and a presence in Korea. Each product also needs its own MFDS approval or notification, held on the Korean side. So for an overseas manufacturer, your choice of importer is effectively your choice of licence holder.
• Registration: MFDS sorts drugs into new drugs, drugs needing data submission, and generics. Imported new drugs need a certificate of manufacture and marketing from the home country and details of the API makers. Since January 2025, MFDS charges a new drug application fee of KRW 410 million. In return it promises a dedicated team, up to 10 meetings with the company, and a decision within 295 days.
• Generics and bioequivalence: generics are approved on bioequivalence, quality (CMC) and GMP data instead of trials. MFDS approves the BE protocol before the study starts. Generics are reviewed by MFDS headquarters and approved by the regional offices.
• Overseas site registration: the importer must register every overseas plant behind an imported product: finished products, DMF APIs, and, since July 2022, APIs imported only for the company's own production. You must register a site before you import from it. The register records each site's staff, facilities and GMP status. MFDS uses it to rate risk and pick sites for inspection.
• On-site inspections: MFDS returned to on-site checks of overseas plants after COVID-19, starting with new drugs and sterile products in 2023. In April 2024 it said it would double overseas inspections from 50 to 100 sites, focusing on falsified batch records and filling and packaging errors. Inspection results can lead to import suspension or cancelled site registration.
• KGMP and DMF: Korea has been a PIC/S member since 2014. For imported DMF APIs, MFDS announced that a GMP certificate from the producing country's authority or a PIC/S member authority, issued to PIC/S or WHO API GMP standards, would replace its own GMP evaluation. It said this would cut API registration from 120 days to 20.
• Pricing: Korea uses a positive list. HIRA's committee assesses new drugs, and the National Health Insurance Service then negotiates the price, usually within 60 days. For generics, the price now depends on two things: your own bioequivalence study and a registered DMF API. From 1 August 2026, the base generic rate fell from 53.55% to 45% of the original price. Generics meeting only one requirement get 36%, and those meeting neither get 29%.
• Without approval: when a needed medicine is withdrawn or unavailable and has no domestic alternative, MFDS uses the Korea Orphan & Essential Drug Center to buy and supply it from overseas. The Center also supports imports for individual patients.
• Watch out for: registration of overseas sites must be kept current, and an unregistered API site can stop a shipment. Do your own BE study and register your API if you want the full generic price.

Australia

• Regulator: the Therapeutic Goods Administration (TGA). A medicine must be on the Australian Register of Therapeutic Goods (ARTG) before it can be sold.
• Sponsor requirement: the sponsor applies for the ARTG entry and is legally responsible for the product. The sponsor must live in Australia, or be an Australian company doing business there with a representative living there. An overseas manufacturer needs a local subsidiary or a third-party sponsor.
• Standard route: dossiers follow the CTD with an Australian Module 1. A 2025 TGA presentation gives a target of 220 working days for a standard evaluation and 150 for priority review. Provisional approval is also available.
• Comparable overseas regulator (COR) routes: the TGA relies on assessment reports from seven comparable regulators: Health Canada, PMDA, Singapore's HSA, Swissmedic, the MHRA, the FDA and the EMA (centralised and decentralised procedures).
  • COR-A, 120 working days: the product and manufacturing must match the overseas-approved version, with GMP evidence. The overseas approval must be no more than one year old. Only the label, product information and risk management plan should need Australian review.
  • COR-B, 175 working days: the TGA can also review some extra data, such as updated stability or an extra manufacturing site. If the extra data are too much, the application becomes a standard one.
  The TGA also shares reviews through the Access Consortium (with Canada, Singapore, Switzerland and the UK) and Project Orbis for cancer medicines.
• GMP clearance for overseas manufacturers: every overseas site needs TGA GMP clearance, and the sponsor applies, not the manufacturer. There are two desk-based pathways:
  • MRA: uses an inspection by a regulator the TGA has an agreement with, carried out in that regulator's own country. It needs less supporting evidence, less assessment time and lower fees.
  • Compliance verification (CV): for other acceptable evidence, such as an inspection carried out outside the inspecting regulator's own country.
  If neither works, the TGA can inspect and issue GMP certification. That can take up to 15 months. File renewals at least six months before a clearance expires.
• Special Access Scheme: lets practitioners use unapproved medicines for individual patients:
  • Category A: for seriously ill patients. Supply straight away and notify within 28 days.
  • Category B: apply and wait for TGA approval.
  • Category C: covers products with an established history of use. Notify within 28 days.
  The Authorised Prescriber scheme lets a doctor supply an unapproved product to a class of patients without approval for each one. Sponsors supplying under these routes file six-monthly supply reports and report adverse events.
• PBS: sponsors apply to the Pharmaceutical Benefits Advisory Committee for subsidy under the Pharmaceutical Benefits Scheme. Its recommendations follow TGA-approved indications. When the first new brand of a bioequivalent or biosimilar medicine is listed, the price drops by up to 25%, and the medicine moves from formulary F1 to F2.
• Watch out for: COR-A needs an identical product and a recent overseas approval, so check that your Australian sites and specifications match before you choose the route. Line up GMP clearances early, because the TGA needs GMP evidence for every site.

New Zealand

• Regulator: Medsafe, part of the Ministry of Health. The Minister's delegate grants consent to distribute a new medicine.
• Sponsor requirement: the sponsor must be a manufacturer, importer or proprietor living in New Zealand. An overseas company needs a New Zealand subsidiary or a local agent with a physical address and a wholesale licence.
• Full and abbreviated routes: Medsafe's target for a first evaluation is 150 working days for a full new medicine application and 75 for an abbreviated one. Under Medsafe's 2020 guideline, the abbreviated route uses unredacted evaluation reports from the TGA, the FDA, Health Canada, the MHRA, the EMA (centralised) or EU member states (decentralised or mutual recognition procedures). Generics can't use it on the strength of an FDA approval, because the FDA doesn't publish evaluation reports for generics.
• Verification pathway: the Medicines Amendment Act 2025 came into force on 19 November 2025. The rules for its "rule of two" verification pathway took effect on 3 July 2026.
  • Two recognised approvals: you need full approval from at least two of the TGA, Health Canada, the EMA (centralised only), HSA, Swissmedic, the MHRA and the FDA. Each must be no more than four years old.
  • An identical product: the product must be the same in all material respects. You submit the full dossier from the main regulator with a New Zealand Module 1, plus both sets of assessment reports.
  • A fast decision: it's due within 30 working days of the fee being paid.
  • Generics and biosimilars qualify, if you show they match the New Zealand innovator. Plasma-derived products, gene therapies and personalised medicines are excluded.
• GMP evidence: every application involving a new site needs a current GMP certificate from a recognised authority, no more than three years old. Recognised authorities include EU regulators under the New Zealand–EU MRA, and certain PIC/S members such as the TGA, FDA, MHRA, Health Canada, MHLW/PMDA and HSA. A TGA GMP clearance is accepted. If you have no acceptable evidence, Medsafe can audit the site at your expense.
• Section 29: unapproved medicines can be supplied to a medical practitioner, nurse practitioner or pharmacist prescriber for a named patient. The last two were added by the 2025 Act. A new section 29A lets any authorised prescriber use an unapproved, Pharmac-funded alternative when a funded medicine is short. Suppliers must notify Medsafe each month and keep supply records.
• Pharmac: Pharmac decides which medicines are publicly funded. Its annual tender covers hundreds of products. The winner gets principal supply status: up to 95% of the funded market for about three years. You need Medsafe consent before a tender can be awarded, so register first.
• Watch out for: PMDA and MFDS approvals don't count towards the verification pathway, and the EU decentralised procedure isn't on its list. Check your approval mix before choosing a route.

A note on China

China is a market of its own, with NMPA registration and its own rules for imported medicines. Rather than repeat it here, see our guide: NMPA explained: China's drug regulator, registration and import rules.

What this means for exporters in India, China, Europe, the US and the region

For every exporter

• Choose markets by the approvals you already hold. Two recognised approvals open New Zealand's verification pathway. One recent COR approval can open Australia's COR-A route. Japan and Korea need a full local review whatever you hold.
• Pick your local partner carefully. In all four markets, the sponsor, importer or MAH holds the approval. Agree in writing who owns the dossier and what happens if you part ways. Our guide to starting an import business covers the licences local partners need.
• Get site approvals moving first. Japan's foreign manufacturer accreditation, Korea's overseas site registration, Australia's GMP clearance and New Zealand's GMP evidence all take time. They often decide your launch date more than the dossier review does.
• Keep your supply chain documented. Distribution and cold-chain controls are checked closely. See our guides to GDP and the cold chain.

Exporters in India

• Generics are the natural route into Australia and New Zealand. PBS brand listings and Pharmac tenders both reward bioequivalent generics. New Zealand's verification pathway accepts generics with two recognised approvals, such as the FDA and MHRA.
• Don't count on an FDA-only file for New Zealand's abbreviated route. The FDA doesn't publish evaluation reports for generics, so pair it with a European or UK approval.
• In Japan and Korea, APIs and partnerships come first. A Japanese MF with a reliable caretaker, or a Korean DMF registration, makes you a supplier that local generic makers can use. In Korea, a registered DMF API also helps your customer keep the higher generic price.

Exporters in China

• APIs are the main opening. Japanese and Korean finished-dose makers need registered API sources. Expect accreditation, site registration and possible on-site inspection before your material can be used.
• Plan for full review of finished products. NMPA approval isn't on the reliance lists in Australia or New Zealand.
• Check Korea's GMP certificate route. MFDS said it would accept a GMP certificate from the producing country's authority or a PIC/S member authority for DMF APIs. Confirm with your Korean partner which certificates it accepts today.

Exporters in Europe

• Your EU approval works hard here. A centralised approval counts for Australia's COR routes and New Zealand's abbreviated and verification routes. A decentralised approval works for the TGA's COR routes and Medsafe's abbreviated route, but not for verification.
• Use your MRA certificates. EU-inspected sites can usually use the MRA pathway for TGA GMP clearance. They can also send Medsafe evidence under the New Zealand–EU MRA and give PMDA an MRA-based certificate.

Exporters in the US

• FDA approval opens fast routes in Australia and New Zealand, and counts as one of the two approvals for verification.
• Japan is reaching out to you. The PMDA office in Washington, D.C. and MEDISO offer free English consultations, a separate Japanese Phase 1 is usually not needed, and NHI pricing rewards filing in Japan early.
• Named-patient demand is real. Australia's Special Access Scheme and Authorised Prescriber scheme, and New Zealand's section 29, bring newer medicines to patients before registration. See our guide to named-patient import programmes.

Exporting within the region, including from Korea and Japan

• A PMDA approval helps in Australia. PMDA is a TGA comparable overseas regulator. It isn't recognised for New Zealand's verification pathway, so pair it with another approval there.
• An MFDS approval doesn't count for reliance in Australia or New Zealand under current rules, so Korean exporters should plan for full review or build on a Western or Singapore approval.
• Australian approval carries into New Zealand. The TGA is recognised for both Medsafe's abbreviated route and verification, and a TGA GMP clearance is accepted as GMP evidence.

Ready to source for your market?

• Sponsors, importers, distributors and tender bidders in Japan, Korea, Australia and New Zealand: post your sourcing RFQ. Our RFQ guide shows what to include, and our DMF guide covers the API questions to ask.
• Hospitals, doctors and patients needing an unapproved medicine: submit an RFP for named-patient import. Our guide to early access programmes explains the paperwork.
• Manufacturers looking to supply the region, whether finished products, APIs or dossier licences: list your company and products so sponsors and importers can find you. Our guide to out-licensing a dossier explains how licence deals are priced.

This guide summarises public regulations and official sources as of October 2026. Pricing rules and reliance routes in this region are changing quickly. Confirm current requirements with the regulator or a local regulatory partner before acting.

Sources

• PIC/S members and accession dates (PIC/S)
• Frequently asked questions: applications, language, accreditation and master files (PMDA)
• Application for accreditation of foreign manufacturers, English reference version (MHLW/PMDA)
• Master File system (PMDA)
• GMP compliance inspection of foreign manufacturers (PMDA, September 2023)
• Biosimilars: guideline, Q&As and early consideration papers (PMDA, 2026)
• Overview of generic drug policy and review points (MHLW, December 2017)
• Measures on drug lag and drug loss, including the Japanese Phase 1 notice (MHLW, August 2025)
• Start in Japan: key messages for overseas companies (PMDA, May 2026)
• PMDA Washington D.C. Office (PMDA, November 2024)
• Regulatory updates on paediatric drug development and the 2025 PMD Act amendment (PMDA, 2025)
• Amendment of the PMD Act in 2025 (Baker McKenzie, May 2025)
• Reducing barriers to entry for drug companies entering Japan (Winston & Strawn, March 2024)
• Japan: marketing business licences and import (Chambers Life Sciences 2026, Nagashima Ohno & Tsunematsu)
• NHI drug price system overview (MHLW)
• FY2024 drug price revision: generics and long-listed products (Chuikyo, August 2023)
• Bringing medicines into Japan: import confirmation (MHLW)
• First three WHO-listed authorities (WHO, October 2023)
• Drug approval process (MFDS)
• South Korea: import and export of pharmaceuticals (Chambers Life Sciences 2026, Lee & Ko)
• South Korea: life sciences (Legal 500, Bae, Kim & Lee, 2026)
• Registration of overseas sites for in-house APIs becomes mandatory (Dailypharm, July 2022)
• Overseas manufacturing site registration grace period ends (Dailypharm, January 2023)
• MFDS resumes on-site inspections of overseas plants (Dailypharm, September 2022)
• Phased return to on-site overseas inspections (Dailypharm, May 2023)
• MFDS to double overseas on-site inspections to 100 sites (Hit News, April 2024)
• API registration cut from 120 to 20 days with GMP certificates (Dailypharm, May 2024)
• New drug review fee and 295-day approval target from January 2025 (Dailypharm, January 2025)
• Time series analysis of Korea's tiered generic pricing policy (Frontiers in Pharmacology, March 2026)
• Generic price rate to fall to 45% (Dailypharm, May 2026)
• 45% generic pricing takes effect in August (Dailypharm, July 2026)
• HIRA evaluation and NHIS price negotiation of new drugs (Dailypharm, December 2020)
• Emergency imports through the Korea Orphan & Essential Drug Center (Dailypharm, June 2026)
• The role of the sponsor (TGA)
• Countries and jurisdictions determined to be comparable overseas regulators (TGA)
• COR timeframes and milestones (TGA)
• Collaboration and expedited pathways (TGA presentation, 2025)
• Sponsor responsibilities for GMP clearance and certification (TGA)
• More overseas sites eligible for the MRA GMP clearance pathway (TGA)
• GMP certification of overseas manufacturers by TGA inspection (TGA)
• Special Access Scheme for individual patients (TGA)
• Supplying unapproved therapeutic goods as a sponsor (TGA)
• PBAC outcomes explained (PBS)
• First new brand price reductions (PBS, October 2026)
• Guideline on the regulation of therapeutic products, Part 2: new medicine applications (Medsafe, October 2020)
• Evaluation timeframes (Medsafe, May 2026)
• Verification pathway for new medicine applications, edition 1.0 (Medsafe, July 2026)
• Verification pathway rules: consultation outcome (Medsafe, May 2026)
• Verification pathway (Ministry of Health NZ, July 2026)
• Medicines Amendment Act 2025 (Medsafe, March 2026)
• Manufacture of medicines: GMP evidence, edition 5.4 (Medsafe, November 2024)
• Unapproved medicines: sections 29 and 29A (Medsafe, December 2025)
• The annual tender for suppliers (Pharmac)
• Draft 2025/26 invitation to tender (Pharmac, July 2025)

Frequently Asked Questions(FAQs)

Can a foreign company hold a marketing approval in Japan?

Yes, through the foreign exceptional approval route, but it must appoint a designated marketing authorisation holder in Japan. Otherwise a Japanese company with a marketing business licence holds the approval, and every overseas plant must be accredited by MHLW.

Does Australia accept approvals from other regulators?

Yes. Under the COR routes, the TGA relies on assessment reports from Health Canada, PMDA, HSA, Swissmedic, the MHRA, the FDA and the EMA. COR-A takes 120 working days and COR-B 175, as long as the product matches the overseas-approved version.

What is New Zealand's verification pathway?

A route in force since 3 July 2026 for medicines already approved by at least two recognised regulators: the TGA, Health Canada, the EMA (centralised), HSA, Swissmedic, the MHRA or the FDA. Approvals must be no more than four years old, the product must be identical, and Medsafe aims to decide within 30 working days. Generics and biosimilars can qualify.

Do overseas plants need to be registered in South Korea?

Yes. The Korean importer must register every overseas site behind an imported product, including API sites, before importing. MFDS uses the register to choose sites for on-site inspection.

How are unapproved medicines supplied to patients in this region?

Australia uses the Special Access Scheme and the Authorised Prescriber scheme. New Zealand uses sections 29 and 29A of the Medicines Act. In Korea, the Korea Orphan & Essential Drug Center imports medicines that aren't otherwise available. In Japan, imports for patients need an import confirmation from MHLW's regional bureaus.