Biotechnology regulation: Views of the authorities, investors, and product developers in Finland

Drug Information Journal

Volumn 38, Issue 3, 2004, Pages 253-264

  Nieminen, Outi ^a   Rahkamo, Leena ^a   Nordström, Katrina ^a  

^a AALTO UNIVERSITY   (Finland)

Author keywords

Biopharmaceuticals; Biopharmacuetical product development; Biotechnology; Regulatory

Indexed keywords

ARTICLE; BIOTECHNOLOGY; DEVICE; DRUG DEVELOPMENT; DRUG MANUFACTURE; EUROPE; FINLAND; FOOD AND DRUG ADMINISTRATION; INSURANCE; PRIORITY JOURNAL; PURIFICATION; SCALE UP; UNITED STATES;

EID: 4344642811     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150403800304     Document Type: Article

References (20)

1. Anonymous Pharma Industry Finland- Biotechnology. http://www.pif.fi/ The%20pharmaceutical %20industry%20today/Biotechnology.html. (Accessed September 5, 2002)
2. Fox S. Business models: Contract biopharmaceutical manufacturing Chem Market Rep. 2001; 260:20-26.
3. Lahteenmaki R. Finnish biotechnology - built on solid foundations. Nature Biotech. 2002; 20:437-440.
4. Statistics Finland-Biotechnology in Figures. http://www.stat.fi/tk/yr/ ttbio_en.html. (Accessed August 25, 2002)
5. Gundersen LE. Training needs in regulatory science for the biopharmaceutical industry. Nature Biotech. 2001;19:1187-1188.
6. The National Agency for Medicines. http://www.nam.fi/english/index.html. (Accessed July 30, 2002).
7. CFR: 21 (1)part 3 sec 3.4.
8. Hirsjarvi S, Hurme H. Tutkimushaastattelu-Teemahaastattelun teoria ja käytäntö. (Theory and practice of Theme Interviewing). 1st edition. Helsinki, Finland: Yliopistopaino; 2000.
9. European Agency for the Evaluation of Medicinal Products. The medicinal product's eligibility for evaluation under the Centralised Procedure. http://www.emea.eu.int/htms/human/presub/q01 .htm. (Accessed September 5, 2002)
10. Kurki P. Medicinal products produced by biotechnology. http://www.nam.fi/ffin.html. (Accessed February 11, 2002)
11. Council directive 93/42/EEC of 14 June 1993 concerning medical devices. The European Union.
12. Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the Community code relating to medicinal products for human use. The European Union.
13. Pharmaceuticals Pricing Board. http://www.hila .fi/english/index.htm. (Accessed September 5, 2002)
14. Jefferys DB. An overview of recent developments in the European regulation of medicine/medical device combination products. Drug Inf J. 2003; 37:39-43.
15. Orphan Medicinal Product Designation in the European Union. http://www.emea.eu.int/pdfs/human/comp/leaflet/661801En.pdf. (Accessed September 4, 2002)
16. Guideline on the format and content of application for designations as orphan medicinal products and on the transfer of designations from one sponsor to another. http.//wwwemea.eu.int/pdfs/human/comp/628300en.pdf. (Accessed September 5, 2002)
17. Regulation EC No 141/2000/EC of the European parliament and of the council of 16 December 1999 on orphan medicinal products. The European Union.
18. The Orphan Drug Act (as amended) of the FDA. http://www.fda.gov/orphan/ oda.htm. (Accessed January 20, 2002)
19. Kurki P. Bioteknologisten laakkeiden kehitys ja viranomaisvaatimukset: yleiskatsaus. (Product development and regulatory requirements of biotechnological medicinal products-an overview) Presentation: Terveyden tutkimuksesta tuotteeksi. (From Health Research to Product) Helsinki, January 30, 2002.
20. Wahlroos H. Terveys- ja lääkepoliittista näk̈kulmaa bioteknologian julkiseen tukemiseen. Health and pharmaceutical policy viewpoint in public finance of biotechnology. http://wwwnam.fi/ffin.html. (Accessed February 11, 2002)