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Draft guidelines and laws (proposals, referrals, drafts etc.)
- Draft Guidelines on Free, Prior and Informed Consent (UN-REDD Programme)
- A comprehensive approach on personal data protection in the European Union (EU Commission)
- A comprehensive approach on personal data protection in the European Union (Opinion of the European Economic and Social Committee)
- Ny djurskyddslag - SOU 2011:75 (Ministry for rural affairs)
- Draft Final Statement of IBC on Human Cloning and International Governance (International Bioethics Committee)
- A Single Market for Intellectual Property Rights Boosting creativity and innovation to provide economic growth, high quality jobs and first class products and services in Europe (Communication from the Commission)
- Stärkt ställning för patienten genom en ny patientlagstiftning - Dir. 2011:25 (Ministry of Health & Social Affairs)
- Genomförande av EU:s direktiv om skydd av djur som används för vetenskapliga ändamål - Ds 2011:12 (Ministry for Rural Affairs)
- En ny upphovsrättslag - SOU 2011:32 (Ministry of Justice)
- En ny biobankslag - SOU 2010:81 (Ministry of Health and Social Affairs)
- En ny biobankslag - SOU 2010:81 (The Swedish Data Inspection Board)
- Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination (draft guidance from U.S. Department of Health and Human Services, Food and Drug Administration, and Center for Drug Evaluation and Research)
- European Parliament legislative resolution of 15 February 2011 on the draft Council decision authorising enhanced cooperation in the area of the creation of unitary patent protection
- Ändring i patentlagen - nya medicinska användningsområden (Referral to the Council on legislation)
- Good participatory practice: guidelines for biomedical HIV prevention trials (UNAIDS Draft)
- Ny yttrandefrihetsgrundlag? Yttrandefrihetskommittén presenterar tre modeller - SOU 2010:68 (Ministry of Justice)
- Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA
- 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)
- 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)
- Report on regulatory aspects of nanomaterials (European Parliament, Committee on the Environment, Public Health and Food Safety)
- 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 (EMA)
- 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)
- SOU
2008:20 - Patentskydd för biotekniska uppfinningar (Ministry of Justice)
- Remissyttrande över slutbetänkandet Patentskydd för biotekniska uppfinningar (Swedish National Council on Medical Ethics)
- 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: 2011-12-14
