Draft guidelines and laws (proposals, referrals, drafts etc.)

Draft Guide for Research Ethics Committee Members (Steering Committee on Bioethics, Council of Europe)
Conclusions on an enhanced patent system in Europe (EU Competitiveness Council)
Draft ENCePP Code of Conduct (EMEA)
Draft Checklist of Methodological Research Standards (EMEA)
Översyn av djurskyddslagstiftningens utformning och innehåll, SOU 2009:57 (Ministry of Agriculture, Food and Consumer Affairs)
Klinisk forskning - Ett lyft för sjukvården. SOU 2009:43 (Ministry of Education)
Proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes (EU Commission)
- The need for non-human primates in biomedical research, production and testing of products and devices (Scientific Committee on Health and Environmental Risks - SCHER)
- Protection of animals used for scientific purposes (text adopted by the Parliament may 2009)
Report on regulatory aspects of nanomaterials (European Parliament, Committee on the Environment, Public Health and Food Safety)
- European Parliament resolution of 24 April 2009 on regulatory aspects of nanomaterials
Genomförande av Inspire-direktivet i svensk lagstiftning; förslag till ny miljöinformationslag och –förordning m.m. (Opinion from the Swedish Data Inspection Board)
- Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE)
WHO’s role and responsibilities in health research. Draft WHO strategy on research for health
Delegation för jämställdhet i högskolan - Dir 2009:7 (Ministry of Education)
Acceptance of clinical trials conducted in third countries (EMEA)
Draft Council of Europe Convention on Access to Official Documents
Skrivelse om behovet av en översyn av regelverken kring forskning där material från djur och människa blandas (Swedish National Council on Medical Ethics)
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
- Yttrande över slutbetänkandet från REACH-utredningen M2007:01 (Naturvårdsverket)
- Kemikalieinspektionens yttrande över Reach-utredningen "Organisation och finansiering" (Kemikalieinspektionens diarienummer 340-1307-08)
- Kemikalietillsyn - organisation och finansiering, SOU 2008:73 (Ministry of Environment)
- Reach - genomförande och sanktioner, SOU 2007:80 (Ministry of Environment)
- Recommendation for Second Reading on the Council common position for adopting a directive of the European Parliament and of the Council amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No .../2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency Committee on the Environment, Public Health and Food Safety)
SOU 2008:20 - Patentskydd för biotekniska uppfinningar (Ministry of Justice)
- Remissyttrande över slutbetänkandet Patentskydd för biotekniska uppfinningar (Swedish National Council on Medical Ethics)
Översyn av lagen (2002:297) om biobanker i hälso- och sjukvården m.m. Dir. 2008:71 (Ministry of Health & Social Affairs)
SOU 2008:3 - Skyddet för den personliga integriteten - Bedömningar och förslag (Ministry of Justice)
- Skyddet för den personliga integriteten SOU 2007:22 (Ministry of Justice)
European Parliament resolution of 16 January 2008: Towards an EU strategy on the rights of the child (2007/2093(INI))
Opinion of the European Economic and Social Committee on ‘Patients' rights’ (2008/C 10/18)
Good Manufacturing Practice (GMP) Annex2 “Manufacture of Biological Products” : Draft revision for public consultation (European Commission)
SOU 2007:57 - Etiskt godkännande av djurförsök - nya former för överprövning. (Ministry of Agriculture)
- Tilläggsdirektiv till Utredningen om överklagande av de djurförsöksetiska nämndernas beslut - Dir. 2006:130 (Swedish Government)
- Överklagande av de djurförsöksetiska nämndernas beslut Dir. 2006:32 Ministry of Agriculture, Food and Consumer Affairs
Regulation of Clinical Research Sponsored by Pharmaceutical Companies: A Proposal (Julio Sotelo, PLoS Medicine)

Last update: 2010-03-09