Blog: From the European Medicines Agency to Project Orbis: new … – The Lancet

• Association of the British Pharmaceutical Industry

UK medicines regulatory policy and global influence in a post-pandemic world.

• Hancock M
• Department of Health and Social Care

Transforming the UK into a life sciences superpower.

• Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency Delivery Plan 2021–2023.

• European Medicines Agency

Brexit: the United Kingdom’s withdrawal from the European Union.

• Medicines & Healthcare products Regulatory Agency

Medicines and Medical Devices Act 2021 Assessment.

• Department of Health and Social Care

Cutting-edge treatments to be fast-tracked to patients through international collaborations.

• Medicines and Healthcare products Regulatory Agency

Project Orbis.

Covid-19 update: in the House of Commons at 4:20 pm on 5th October 2020.

• Medicines and Healthcare products Regulatory Agency

Access Consortium.

• de Claro RA
• Spillman D
• Hotaki LT
• et al.

Project Orbis: global collaborative review program.

Clin Cancer Res. 2020; 26: 6412-6416

• US Food and Drug Administration

Project Orbis.

• Lythgoe MP
• Desai A
• Gyawali B
• et al.

Cancer therapy approval timings, review speed, and publication of pivotal registration trials in the US and Europe, 2010–2019.

JAMA Netw Open. 2022; 5e2216183

• US Food and Drug Administration

Project Orbis: strengthening international collaboration for oncology product reviews, faster patient access to innovative therapies.

• Downing NS
• Zhang AD
• Ross JS

Regulatory review of new therapeutic agents—FDA versus EMA, 2011–2015.

N Engl J Med. 2017; 376: 1386-1387

• Lythgoe M
• Krell J
• Warner JL
• Desai A
• Khaki AR

Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals.

J Clin Oncol. 2021; 391575

Project Orbis: the UK experience after 1 year.

Lancet Oncol. 2022; 23: 978-981

• US Food and Drug Administration

Priority review.

• Medicines and Healthcare products Regulatory Agency

UK medicines regulator issues its first authorisation under Project Orbis.

Lung cancer patients to get breakthrough drug on NHS.

NHS to offer new drug that halves the risk of cancer returning.

Triple negative incurable breast cancer patients denied extra time with loved ones as drug company fails to reach agreement to secure immediate access to new treatment.

Access Consortium—strategic plan 2021–2024.

• Medicines and Healthcare products Regulatory Agency

Access new active substance and biosimilar work sharing initiatives.

New drug approvals in six major authorities 2011–2020: focus on facilitated regulatory pathways and worksharing.

• Medicines and Healthcare products Regulatory Agency

Innovative licensing and access Pathway.

• Medicines and Healthcare products Regulatory Agency

Rolling review for marketing authorisation applications.

• Medicines and Healthcare products Regulatory Agency

150-day assessment for national applications for medicines.

• Medicines and Healthcare products Regulatory Agency

European Commission (EC) decision reliance procedure.

• Medicines and Healthcare products Regulatory Agency

Guidance on the handling of applications for Centrally Authorised Products (CAPs).

• Medicines and Healthcare products Regulatory Agency

Conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.

• European Medicines Agency

Conditional marketing authorisation.

• Mehta GU
• de Claro RA
• Pazdur R

Accelerated approval is not conditional approval: insights from international expedited approval programs.

JAMA Oncol. 2022; 8: 335-336

• US Department of Health and Human Services

Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics.

The UK Innovative Licensing and Access Pathway—a new paradigm in market access.

• Pignatti F
• Wilking U
• Postmus D
• Wilking N
• Delgado J
• Bergh J

The value of anticancer drugs—a regulatory view.

Nat Rev Clin Oncol. 2021; 19: 207-215

• Cherny NI
• Dafni U
• Bogaerts J
• et al.

ESMO-magnitude of clinical benefit scale version 1.1.

Ann Oncol. 2017; 28: 2340-2366

• National Institute for Health and Care Excellence

NICE collaboration on streamlined licensing and patient access process for new medicines opened on January 1st.

• Medicines and Healthcare products Regulatory Agency

The target development profile toolkit.

Target product profiles.

First innovation passport awarded to help support development and access to cutting-edge medicines.

UK regulator issues 41 ‘innovation passports’ in first year of new pathway.

• Feng C
• Virparia R
• Mui ETK

Analysis of the Real-Time Oncology Review (RTOR) pilot program for approvals of new molecular entities.

Ther Innov Regul Sci. 2021; 55: 881-888

• Medicines and Healthcare products Regulatory Agency

Apply for the early access to medicines scheme (EAMS).

Innovation-Over 500 UK patinets gain access to new skin cancer treatment.

• European Medicines Agency

Brexit-related guidance for companies.

EU exit—frequently asked questions.

NI Protocol preventing approval of life-saving cancer treatment.

Brexit: NI will get medicine at same time as GB, EU proposes.

EU-UK relations: commission proposes solution.

• Medicines and Healthcare products Regulatory Agency

The Northern Ireland MHRA authorised route (NIMAR).

• Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency delivery plan 2021–2023.

Putting patients first in medicines regulation?.

BMJ. 2021; 375n2883

• Department of Health and Social Care

Saving and improving lives: the future of UK clinical research delivery.

Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review.

Contemp Clin Trials Commun. 2018; 11: 156-164

• Boyle JM
• Hegarty G
• Frampton C
• et al.

Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: a retrospective cohort study.

Eur J Cancer. 2021; 155: 136-144

• Department of Health and Social Care

The future of clinical research delivery: 2022 to 2025 implementation plan.

• Middleton G
• Fletcher P
• Popat S
• et al.

The National Lung Matrix Trial of personalized therapy in lung cancer.

Nature. 2020; 583: 807-812

• Blagden SP
• Billingham L
• Brown LC
• et al.

Effective delivery of Complex Innovative Design (CID) cancer trials—a consensus statement.

British Journal of Cancer. 2020; 122: 473-482

• Medicines and Healthcare products Regulator Agency

MHRA joins international partnerships to set global standards for medicines and medical devices regulation.

• European Medicines Agency

Clinical trials regulation.

Medicines and Healthcare products Regulatory Agency. The past, the present, and the future of clinical trials transparency in the UK.

Clinical trials landscape UK: GlobalData review January to December 2019.

• Advanced Therapy Treatment Centres
• Advanced Therapy Treatment Centres network’s Industry Advisory Group

National Cell and Gene Therapy Vision for the UK.

Importing oncology trials from China: a bridge over troubled waters?.

Lancet Oncol. 2022; 23: 323-325

• Benjamin DJ
• Prasad V
• Lythgoe MP

FDA decisions on new oncological drugs.

Lancet Oncol. 2022; 23: 585-586

• Department of Health and Social Care

Health and Social Care Secretary to launch new 10-year ‘national war on cancer’.

2021 FDA approvals.

Nat Rev Drug Discov. 2022; 21: 83-88

• European Medicines Agency

Human medicines highlights 2021.

Top pharma markets by country market share 2020.

Oncology market (by cancer diagnostics & treatment: cancer diagnostics and cancer treatment; by indication: lungs cancer, colorectal cancer, breast cancer, liver cancer, bladder cancer, head & neck cancer, prostate cancer, and others)—global industry analysis, size, share, growth, trends, regional outlook, and forecast 2022–2030.

How the US Food and Drug Administration’s approval of aducanumab for Alzheimer’s disease has implication for oncology and beyond.

Eur J Cancer. 2021; 157: 68-70

• Hwang TJ
• Trinh QD
• Tibau A
• Vokinger KN

Reforms to accelerated approval of new medicines: long overdue.

Lancet. 2022; 400: 357-358

• Vokinger KN
• Kesselheim AS
• Glaus CEG
• Hwang TJ

Therapeutic value of drugs granted accelerated approval or conditional marketing authorization in the US and Europe from 2007 to 2021.

JAMA Health Forum. 2022; 3e222685

• Powell K
• Lythgoe MP
• Prasad V

The Oncologic Drugs Advisory Committee votes of April 2021—implications for the fate of accelerated approval.

JAMA Oncol. 2021; 7: 1607-1609

“Dangling” accelerated approvals in oncology.

N Engl J Med. 2021; 384: e68

• Sachs RE
• Donohue JM
• Dusetzina SB

Accelerated approval—taking the FDA’s concerns seriously.

N Engl J Med. 2022; 387: 199-201

• Gyawali B
• Rome BN
• Kesselheim AS

Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.

BMJ. 2021; 374n1959