EMA支持歐盟的兒童用藥物
來自專欄藥品註冊管理
EMA Supporting medicines for children in the EU
EMA支持歐盟的兒童用藥物
The European Union』s Paediatric Regulation fosters the authorisation of more medicines
for children, better information, better research and development.
歐盟的兒科條例促進了兒童用藥物的授權，更好的信息，更好的研究和開發。
1.Small humans, big needs 人小，需求大
Children and newborn babies often react differently to medicines than adults. However, information on the use in children is not always available, and specific, more suitable forms may be required. Therefore, it is important that medicines are appropriately studied and demonstrated to be safe and effective for children.
與成年人相比，兒童和新生兒通常對藥物的反應不同。然而，通常沒有明確規定兒童用藥物的信息，可能需要更多合適的規格。因此，合理的研究和證明藥物對於兒童是安全和有效是非常重要的。
In 2007, the Paediatric Regulation introduced a system of obligations, rewards and incentives to encourage manufacturers to research and develop medicines for children』s specific therapeutic needs.
2007年，兒科條例引入了一套義務，獎勵與激勵的系統以鼓勵生產商研究和開發兒童的特殊治療需求的藥物。
200 new medicines for children (2007–2017) 200個兒童用新葯（2007~2017）
25% of all new medicines are for children 25%的新藥用於兒童
2. More medicines, better knowledge 更多藥物，更好知識
In some therapeutic areas, new indications for medicines (e.g. infectious diseases, rheumatology) have led to positive changes in the way children are treated. In other areas, (e.g. oncology, neonatology) the Paediatric Regulation was less effective. EMA is taking steps to improve the situation in these areas.
在某些治療領域，藥物的新適應症（如傳染病、風濕病）已經導致兒童治療方式的積極變化。在其他領域（如腫瘤科、新生兒學），兒科條例效果較差。EMA正在採取措施改善這些領域的情況。
New medicines for children in selected therapeutic areas (2007–2015)
所篩選治療領域的兒童用新葯（2007~2015）
14 Infectious diseases; 傳染病
2 Oncology; 腫瘤
8 Rheumatology; 風濕病
6 Cardiovascular diseases; 心血管疾病
1 Neonatology; 新生兒學
Positive impact of the Regulation — more medicines available
條例的積極影響—更多的藥物可用
3. Support for paediatric research 支持兒科藥物研究
The Paediatric Regulation has created EMA』s Paediatric Committee (PDCO) — an expert group that reviews Paediatric Investigation Plans (PIPs).
兒科條例已經建立看EMA的兒科委員會（PDCO）—一個審查兒科調查計劃（PIPs）的專家組。
A Paediatric Investigation Plan (PIP) is a plan agreed early in the development of a medicine between the company and the PDCO. It describes what studies in children will be carried out to get relevant data for the evaluation of a medicine for children. The purpose of PIPs is to boost authorisation of more and better medicines for children.
兒科調查計劃（PIP）是在某一藥物開發早期公司和兒科委員會之間達成協議的計劃。該計劃描述了為了獲得用於兒童用藥評估相關數據而在兒童身上進行的研究。該計劃的目的是促進更多和更好的兒童用藥物的授權。
European Network of Paediatric Research at EMA (Enpr-EMA)
EMA的歐洲兒科研究網路（Enpr-EMA）
Enpr-EMA is a network of more than 40 research networks, investigators and centres with recognised expertise in performing clinical studies in children. Its objectives include collaboration between networks in the EU and beyond and facilitation of high quality studies to increase the availability of medicines for children.
Enpr-EMA是一個超過由40個研究網路、研究研究和中心組成的網路，在兒童臨床研究方面有公認的專業知識。其目標是包括歐盟內外網路之間的合作以及促進高質量研究，以增加兒童藥品的供應。
International collaboration 國際合作
International collaboration between regulators helps to optimise the developments of new medicines by aligning the evidence needs. EMA, the U.S. Food and Drug Administration (FDA) and other regulators discuss paediatric medicine developments at monthly meetings. In 2017, EMA and the FDA were aligned in their views in 73% of the medicines for children they considered.
監管機構的國際合作有助於通過校正明顯的需求優化新葯的開發。EMA，美國食品藥品監督管理局（FDA）和其他的監管機構在月度會議上討論兒科藥物的開發。2017年，EMA和FDA在他們認為的73%的兒童藥物方面保持一致。
4. A change in thinking 思維的變化
The Paediatric Regulation has led to more awareness on the need to study medicines in children. Research of medicines in children is now standard practice in the development of medicines.
兒科條例已經引起了對兒童用藥物需求的更多關注。兒童用藥物的研究是藥物開發的標準實踐。
原文來源於：國際藥品註冊網&廣州佳鑫醫藥科技有限公司
本譯文著作權歸作者所有，非經作者或國際藥品註冊網授權，不得轉載。
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