From 2025 to 2026, the biopharmaceutical and healthcare industries will see the three pillars of price, regulation, and supply chain operating simultaneously. Key variables include strengthening safety and data regulations
for pharmaceuticals and medical devices in the US and EU , a reduction in dependence on China for active pharmaceutical ingredients (APIs) , and increased certification lead times following the EU IVDR transition . While tariff benefits from FTAs will be relatively small, mutual recognition of regulations, GMP/ICH, and the mutual use of clinical data will determine real competitiveness.
Risk factors | 2025-26 Outlook | Influence (1~5) | Implications |
|---|---|---|---|
| Complete transition to the EU IVDR and MDR | Increased certification lead time | 5 | Pre-clinical and performance evaluations secured, technical documentation improved |
| US Regulation and Procurement | Intensifying competition in generics and biosimilars | 4 | Diversification of drug prices and supply contracts, strict compliance with cGMP |
| API/Raw Materials Supply Chain | Reducing China's concentration and diversifying into India and ASEAN | 4 | Multi-source procurement/RVC/cumulative utilization |
| Data and Privacy | Restrictions on cross-border transfer of medical data | 3 | HIPAA/GDPR Compliance, Utilizing Digital Trade Provisions |
| Exchange rate/logistics | Moderate volatility | 2 | Cold Chain and Insurance Optimization |
Finished pharmaceutical products (HS 3004) generally enjoy low tariffs and zero tariffs in major developed markets, while medical devices (HS 9018, etc.) also enjoy relatively low tariff burdens through FTA/ITA channels .
In practice, the bottlenecks are not tariffs, but rather regulations and certifications (GMP, ICH, CE-IVDR, FDA 510(k)/PMA), clinical/performance data, and QMS documentation .
Raw materials (APIs, HS 3003, HS 2933, etc.) still have significant MFN variances, making FTA implementation a significant benefit.
division | FTA/ITA applicability (trend) | On-site difficulties | Management Points |
|---|---|---|---|
| Finished pharmaceutical products (HS3004) | Multi-market tariff-free/low-rate | Drug price, approval, and PV requirements | cGMP·PV·Label·Code Conformity |
| Pharmaceutical raw materials (API) (HS2933, etc.) | MFN deviation exists | DMF·Origin·Impurity Management | DMF Updates and RVC/CTH Utilization |
| Biomaterials/Plasma/Vaccines (HS3002) | Step-by-step permit and quarantine | Cold chain and biosafety | GDP·BIO-risk SOP |
| Medical devices (HS9018, etc.) | Lower rates through ITA/FTA | CE-IVDR/FDA certified | Clinical·Performance·QMS (ISO13485) |
In the US and EU, regulations, procurement, and data are more substantial barriers than tariffs.
In China and emerging markets, MFN tariffs, certification, and clinical localization act as parallel barriers.
market | Representative HS (example) | MFN tariff (scope) | When FTA/ITA is applied (trend) | Non-tariff barriers (example) | Comments |
|---|---|---|---|---|---|
| USA | 3004, 9018 | Generally low rate | 0% high frequency | FDA (PDUFA/510k/PMA), GxP | Large variables in drug prices and procurement |
| EU | 3004, 9018 | 0~6% mixed | 0% majority | CE-MDR/IVDR, GDPR | Be mindful of IVDR transition lead times |
| china | 3004, 9018 | 4~8% | Differentiation by agreement | NMPA, Clinical Localization | Parallel domestic production policy |
| India/ASEAN | API/device mix | 5~10%+ | RCEP/Bilateral FTA reduction | CDSCO, SIRIM, etc. | Certification and label localization are required |
Note: It varies depending on HS, product group, and use, so it is recommended to check the latest HTS/TARIC before customs clearance.
Although not directly subject to CBAM, energy, waste, and packaging regulations for pharmaceutical and medical device production processes are reflected as costs.
Furthermore, **clinical and experimental ethics, supply chain human rights, and environmental due diligence (ESG due diligence legislation)** are expanding.
policy | Core requirements | Enforcement/Strengthening | Influence (1~5) | react |
|---|---|---|---|---|
| CE-IVDR/MDR | Clinical, Performance, and QMS Verification | Transitioning and strengthening | 5 | Certification Roadmap and Preemptive NB Arrangement |
| GMP/GDP/GCP | Manufacturing, distribution, and clinical standards | Always | 5 | Data Integrity/CSV (Combal) |
| Packaging and Circular Economy | Pharmaceutical packaging, disposal, and recycling | enlargement | 3 | Eco-friendly packaging and LCA |
| ESG due diligence | Obligation to conduct human rights and environmental due diligence | enlargement | 3 | Supply Chain Due Diligence and Contractual Clause Standardization |
Korea: R&D Hub for Biosimilars, High-Tech Generics, Digital Health, and AI Diagnostics
US/EU: Localization of high-value-added therapeutic areas, clinical development, and IVDR-compliant devices (optimization of licensing/procurement)
India and ASEAN: API/small and medium-sized enterprises diversification (price and delivery advantages) + RCEP accumulation
Latin America and the Middle East: Generic and Vaccine Partnerships Targeting Infectious and Chronic Diseases
Combines public statistics with news and policy sentiment (α), global sentiment (β), and sector sentiment (λ).
Pharmaceuticals and medical devices are highly sensitive to regulatory and approval news, so ΔSignal fluctuations are quickly reflected.
variable | Δ(%) or exponent | analysis |
|---|---|---|
| ΔExport_now | +2.3 | Improvement of exports of finished products and medical devices |
| ΔImport_now | +1.5 | Strengthening API and raw material imports |
| ΔPrice_now | +0.4 | Stable unit prices in high value-added treatment areas |
| ΔSignal_now | +0.030 | Positive momentum for regulation and permitting |
| ΔFTAEffect | +0.29 | Indirect effects of duty-free and shortened permit requirements |
| Forecast_3M | +0.49 | A gradual improvement is expected within three months. |
Formula (summary): Forecast_3M = 0.5·ΔSignal + 0.3·ΔFTAEffect + 0.2·ΔPrice
field | Suggestion | Executor | Expected effect |
|---|---|---|---|
| Simultaneous support for regulation and certification | FDA/CE-IVDR integrated consulting and NB acquisition | Ministry of Trade, Industry and Energy·KOTRA | Shortened certification lead time |
| API diversification | India-ASEAN Long-Term Offtake + RVC Guide | Korea Customs Service and Trade Headquarters | Cost and risk reduction |
| Digital Health | Reflecting international standards for telemedicine and SaMD | Health authorities and trade authorities | Opening up new markets |
| Data migration | Standardizing Cross-Border Transfer of Medical Data | Trade Negotiation Headquarters | Clinical and AI learning efficiency |
| green procurement | Eco-friendly packaging and LCA standard incentives | Ministry of Environment and Public Procurement Service | ESG cost offset |
In bio, pharmaceutical, and healthcare, regulation, certification, and data are key to competitiveness, rather than tariffs.
FTA effectiveness = Redefined as mutual regulatory recognition + origin/accumulation + procurement access .
Forecast_3M: +0.49 — A signal of gradual improvement; IVDR and FDA response capabilities are key to export expansion.
Recommended strategies: ① Preemptive certification roadmap ② API diversification and accumulation ③ Reflection of data standards and digital health FTA ④ Eco-friendly packaging and LCA.
