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

54 Total results for product and free and sample content found

世界の薬事規制動向&情報を配信

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.

Topic Regulation Brexit Pharma-Brexit

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

The Times They Are A-Changin’: Opportunities In Medtech Regulation For The UK After Brexit

The turn of the year is a chance to reflect on times past and the future, to make resolutions and look ahead to changes for the better. With Brexit in mind, this is the time to prophesize on UK medtech’s immediate future.

Topic Regulation Market Access Medtech-Brexit

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

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Topic Approvals Compliance Regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Clears CDC Diagnostic For COVID-19 And Influenza

The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.

Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

EU Countries Test Offering Simultaneous Scientific Advice

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

Topic EU Innovation Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

China Regulatory Express Former CFDA Commissioner Bi Makes Comeback

Ex-China FDA Commissioner Bi Jingquan’s new role, a waiver of bioequivalence testing for hundreds of drugs, data accuracy requirements and a new crackdown on compliance issues.

Topic China Regulation Compliance

Generics Bulletin: ジェネリック&バイオシミラーニュース

Celltrion's Remsima SC Ready For Early 2020 Launch

Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.

Topic Biosimilars Launches Regulation

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。