Laws and Regulations Regarding Taiwan's Biotechnology Industry

I. Regarding Biotechnology and Pharmaceuticals

1. Pharmaceutical Affairs Law
2. Pharmaceutical Affairs Law: Details
3. Nutritional Product Management Law
4. Rare Disease Prevention and Drug Law
5. GMP for Medical Devices
6. cGMP for Pharmaceutical Drugs
7. Good Manufacturing Practice for Pharmaceuticals
8. Standard for Establishing Pharmaceutical Manufacturing Factories
9. Guideline for Good Clinical Practice
10. Ethical Guidelines of Placental Dry Cell Research

II. Regarding Agriculture

1. Plant Seed Law
2. Plant Seed Law: Details
3. Plant Quarantine and Inspection Law
4. Environmental Drug Management Law
5. Regulations Governing Management Practices for Transgenic Animal Field Tests, and Guidelines for the Management of Biological Safety Assessments
6. Rules Governing Veterinary-use Drugs
7. Rules Governing Veterinary-use Drugs: Details
8. Regulations Governing Management Practices for Transgenic Plant Field Tests
9. Regulations Governing Management Practices for Transgenic Plants Field Tests: Details

III. Regarding Intellectual Property Rights

1. Patent Law
2. Trademark Law
3. Copyright Law
4. Trade Secrets Act
5. Plant Seed Law
6. Measures for Safekeeping of Microbiology-Related Patent Applications
7. Standards for Assessing Related Biological Inventions
8. Guidelines for Ownership and Use of the Scientific Technological R&D Results of the Government
9. Guidelines for Ownership and Use of Results from Research Subsidized or Commissioned by the Ministry of Economic Affairs
10. Guidelines for Rights to R&D Results of the National Science Council
11. Guidelines for Managing Authorized Use of Biological Drug Production Technology by Department of Health Personnel
12. The Foundation Law for technology development

IV. Regarding Tax Benefits and Incentives

1. Statute for Upgrading Industries
2. Agricultural Development Regulations
3. Scope of Venture Capital Business and Consulting Guidelines
4. Rules for Encouraging Pharmaceutical Technology Research and Development
5. Regulations Governing Tax Incentives for Operations Headquarters and Bylaws
6. Tax Deduction Measures for Company R&D and Personnel Training Expenditures
7. Guidelines for Considering Expenditures Incurred by Companies Involved in R&D Commissioned by Local Biotech and Pharmaceutical Companies as Investment.
8. Incentive Measures for R&D and Manufacture of Drugs for Rare Diseases
9. Incentive Measures for Emergent Important Industries Belonging to Agriculture
10. Incentive Measures for Emergent Important Strategic Industries Belonging to Manufacturing and Technology Service
11. IDB of MOEA Contracted Proposal for Points Regarding Industry Technology and Production to be Developed Successfully and Having Marketability to relax the listing requirement of local biotechnology companies to apply for listing on the Taiwan Stock Exchange and OTC Exchange.