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Draft guidelines and laws (proposals, referrals, drafts etc.)
- Vissa register för forskning om vad arv och miljö betyder för människors hälsa. Prop. 2012/13:163 (Ministry of Education)
- Promemoria med utkast till lagrådsremiss Register för viss forskning U2013/527/F (Ministry of Education & Science)
- The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations
- Draft revised version of the Declaration of Helsinki (World Medical Association)
- Förutsättningar för registerbaserad forskning - Dir. 2013:8 (Ministry of Education & Science)
- Stärkt ställning för patienten genom
en ny patientlagstiftning - Dir. 2011:25 (Ministry of Health & Social Affairs)
- Patientlag - Delbetänkande av Patientmaktsutredningen - SOU 2013:2 (Ministry of Health and Social Affairs)
- Proposal for a regulation of the European Parliament and of the Council
on clinical trials on medicinal products for human use, and repealing Directive
2001/20/EC
- Position of the European Group on Ethics on the EC Proposal for a regulation of the European Parliament and the Council on Clinical Trials COM (2012) 369 final
- CPME Statement on the European Commission proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- 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)
- Kommissionens förslag till dataskyddsförordning
(KOM (2012) 11 slutlig) (Opinion from the Swedish Data Inspection Board) - Statement on the Proposal for a Regulation on the General Data Protection Regulation 2012/0011(COD)
- En nationell handlingsplan för säker användning och hantering av nanomaterial - Dir. 2012:89 (Ministry of Environment)
- Nationella patent på engelska? SOU 2012:19 (Ministry of Enterprise, Energy and Communications)
- Ett enhetligt patenskydd i EU och en ny patentlag - Dir. 2012:99 (Ministry of Justitice)
- Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- European Parliament legislative resolution of 11 September 2012 on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance
- European Parliament legislative resolution of 11 September 2012 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance
- Commission Recommendation of 17.7.2012 on access to and preservation of scientific information
- Draft transparency policy (European Medicines Agency)
- Beslutsoförmögna personers ställning i hälso- och sjukvård, tandvård, socialtjänst - Dir. 2012:72 (Ministry of Health and Social Affairs)
- Draft Guidelines on Free, Prior and Informed Consent (UN-REDD Programme)
- 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)
- 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)
- 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)
Last update: 2013-06-18
