skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration
  • Close Icon

Refine Results

Clear All

Specialism

もっと見る

Resources

もっと見る

もっと見る

Products

もっと見る

もっと見る

17 Total results for product and free and sample content found

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.

Topic Pharma-Brexit brexit Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Desperate Measures: How To Soften The Impact Of No-Deal Brexit

Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.

Topic Pharma-Brexit brexit EU

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit: New Rules Will Hit Parallel Trade From UK to EU

From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries. 

Topic EU Pharma-Brexit Brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit Issues Lead NICE To Delay Methods Review

England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”

Topic brexit Pharma-Brexit EU

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

Topic Pharma-Brexit brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Firms Face Thousands Of Variations To Update Safety Information

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Topic Pharma-Brexit Safety brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Act Quickly On Converted EU Product Approvals GB Firms Urged

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year. 

Topic Pharma-Brexit brexit drug-approval

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

How To Get Orphan Drug Status In Great Britain From 2021

Pink Sheet Brexit Orphan Drug Status

Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period

Topic Pharma-Brexit Rare Diseases

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.

Topic EU Pharma-Brexit brexit

お問い合わせ&レポートストア

専任スタッフによるデモンストレーションを兼ねたサービスの詳しいご説明、または無料トライアルを常時受け付けています。ご希望の場合は下記のフォームよりお気軽にお申し込みください。

*一部のサービスでは無料トライアルをご利用になれません。

新型コロナウイルス感染拡大防止のため在宅勤務を実施しています。お問合せの際は下記メールアドレスまたは各営業スタッフまでご連絡下さいますようご協力をお願い申し上げます。

インフォーマインテリジェンス合同会社
ファーマインテリジェンス
inquiry.jp@informa.com

*Omdia(ICT産業の情報)に関するお問い合わせはこちら
Contact_OmdiaJapan@omdia.com


オンラインショップのレポートストアでは、医療用医薬品の市場調査・分析レポートを常時1000本以上販売しています。レポート1本単位で購入でき、オンラインでご提供いたします。

お探しの情報が見つからない場合はお問い合わせ先までお気軽にご連絡ください。