. 2022 Dec 3;57(3):484–514. doi: 10.1007/s43441-022-00480-3

Table 3.

Overview of shortened registration pathways (excluding reliance)

Country	Procedure name	Available since	Eligibility	Scope	Characteristics	Review timelines	References
Australia^a,b	Priority review	2017	Criteria: • Serious condition; • Comparison against registered therapeutic goods (medicines with provisional registration are excluded from comparison); • Major therapeutic advance	New prescription medicine or new indication based on full dossier (i.e., provisional approved medicines are excluded)	Timing of request: 3 months prior to submission of an application for marketing authorization (MAA). 20 days for decision (excluding response time to information requests). Optional pre-submission meeting 2 months before request If eligible Pre-submission Planning form to be completed before submitting (max. 6 months)	Standard regulatory review: 255 working days Priority review: 150 working days Median time to approval (NAS) 2021: Expedited: 221 days Standard: 354 days	[15, 55, 56]
Brazil^a	Priority review resolution	2018	One of the following criteria: • New or innovative products; • Significant improvement in emergent/neglected/rare diseases, vaccines for national immunization programme, public health emergencies, first generic	New applications for marketing authorization, post-approval changes (new indications, generic applications in the context of shortages) and clinical trial applications	Timing of request: at the time of the marketing authorization application and 60 days after 1st international submission Procedure paused (clock stop) in case of questions Conditions: • Medicine must be marketed within 365 days after register approval; • New chemical entities must submit price request within 30 days after register approval	Standard regulatory review (calendar days): 365 for MAA and 180 for post-marketing changes Priority review (calendar days): 120 for MAA, 60 for post-marketing changes, 45 for clinical trials ANVISA can request extension of 1/3 of each period Median time to approval (NAS) 2021: no data available	[57]
Canada^a,b	Priority review	2005	Medicine for a serious life-threatening or severely debilitating disease or condition: • No alternative therapy is currently marketed or, • Expected improvement of overall Benefit/Risk compared to existing therapies/preventatives or diagnostic agents for disease/condition that is not adequately managed by a drug marketed in Canada	New Drug Submission or supplemental New Drug Submission	Timing of request: Written request in advance of the filing of the drug submission to the Director of the appropriate bureau at Health Canada NDS to be submitted within 60 calendar days but not prior to the date of issuance of the acceptance letter Data include substantial evidence of clinical effectiveness	Standard Regulatory Review: 450 days Priority Review target: 180 calendar days Median time to approval (NAS) 2021: Expedited: 207 days Standard: 343 days	[15, 58, 59]
China	Priority review	2020	Intended for: • Medicines in the area of unmet medical need • Shortages of drugs with urgent clinical need • Innovative drugs • Improved new drugs for major infections and rare diseases • Paediatric medicines • Medicines eligible for conditional approval (see Table 1) and Breakthrough therapy (see Table 2) • Other circumstances considered by National Medical Products Agency	New applications or new indications	Timing of request: prior to submission. Before submitting an application for priority review, the applicant must contact the centre for drug evaluation to discuss whether the existing clinical data meet the requirements of the eligibility criteria. If eligible application for priority review to be submitted with supporting materials at the time of MAA	Standard Regulatory review: 16–20 months Priority review standard: 11–13 months (130 working days) Priority review for orphan drugs authorized overseas but not marketed in China: 70 working days Median time to approval 2021: no data available Priority review will switch to standard review if conditions are no longer met	[31]
China	Special review and approval procedure	2020	Public Health emergencies, threats	New applications and new indications	Characterised by regulatory flexibility and short evaluation timelines. Use of the medicine may be limited to the emergency period only	Standard regulatory review Special review and approval	[31]
European Union	Accelerated assessment	2004	Major interest to public health: • Unmet medical need or • Major therapeutic advantage/innovation	New applications	The intent to request is to be discussed in advance. Justification is needed that early access of the product is of major interest to public health	Pre-submission meeting highly recommended (6–7 months before MAA). Requests should be submitted at least 2–3 months before submitting the MAA Standard regulatory review: 210 days (excl. clock-stop) Accelerated assessment: 150 days (excl. clock-stop) Median time to approval (NAS) 2021: Expedited: 250 days Standard: 434 days Can revert to regular timeline if it is deemed no longer appropriate to conduct review under accelerated conditions	[15, 60, 61]
Japan	Priority Review	2020	• Orphan drug • Drugs designated for pioneering drugs (Sakigake) review (see Table 2) • Pioneering drugs, devices or regenerative drugs (regular or special purpose) • New drugs, devices or regenerative drugs indicated for a serious disease or with efficacy/safety clearly medically superior to existing treatment modalities	New applications or new indications/major advances	Timing of request: prior to submission. Request for priority review to be indicated in the application form, including reason for eligibility. If available, evaluation report based on consultation on applicability drug priority review products to be attached. PMDA compiles opinion and MHLW will decide. Decision announced at the time of approval	Standard regulatory review: 12 months Priority review including orphan drugs: 9 months,Pioneering Drugs (Sakigake) 6 months. Median time to approval (NAS) 2021: Expedited: 266 days Standard: 331 days	[15, 38, 62]
Republic of Korea	Priority Review	2021	Medicines for: • Life-threatening or critical diseases with no existing treatment or offering significant efficacy improvement • Public health crisis		Timing of request: Prior to submission Reviewed in 30 working days. Outcome is announced on the agency webpage	Standard regulatory review: 120 days when DMF review is included, 90 days when not Priority review reduces timeline by 75% compared to standard Median time to approval (NAS) 2021: no data available	[63]
Republic of Korea	Rolling submission	2021	New biotech like Cell therapy and Gene therapy and biosimilars	Expedited submission	Standard regulatory review: 120 days when DMF review is included, 90 days when not		[40, 63–67]
Singapore^a,b	Shortened registration procedure—priority review	2017	• Only applicable to products eligible for abridged evaluation pathway and that hence have already been evaluated and approved by at least one drug regulatory authority (any) • Product for a life-saving disease where there are unmet medical needs • Product demonstrates potential to address the unmet medical need (lack of alternative treatment, significant improvement in efficacy/safety) • Disease conditions that are of local public health concern will be given primary consideration	Initial MAA	To be requested at the time of application for Marketing authorisation Justification to be provided in Module 1 To be granted/denied at the time of acceptance of the MAA application	Standard regulatory review: 270 working days (excl. clock-stops) Abridged evaluation: 180 working days (excl. clock stops) No dedicated official timelines for priority review available but expected to be shorter than abridged pathway timelines. Median time to approval 2021: no data available	[68]
Switzerland^a,b	Fast-track procedure (FTP)	Initial Introduction in 1997	• Promising prevention against, treatment for a severe disabling or life-threatening disease • Currently available treatment unavailable or unsatisfactory • Expected high therapeutic benefit • Clinically relevant trial	Initial MAA or variations	Request to be submitted as part of an Accelerated Application Hearing between 2–12 months prior to the planned submission. Decision will be made within 30 days Dossier may be submitted 2 months after granting of FTP	Standard regulatory review: 330 calendar days, indication 270 calendar days FTP review: 140 calendar days (5 days validation, 1st round 65 days, 2nd round 50 days, labelling 20 days—excl. clock-stops) Median time to approval (NAS) 2021: Expedited: 245 days Standard: 399 days	[15, 69]
Switzerland^a,b	Procedure with prior notification (PPN)	2013	Any new active substance or approved medicine	Initial MAA or indication extension	Special service offered at twice the normal fee	Standard regulatory review: 330 calendar days, indication 270 calendar days PPN review new MAA: 264 calendar days PPN review extension indication: 216 calendar days Median time to approval (NAS) 2021: Expedited: 245 days Standard: 399 days	[15, 70]
Taiwan	Priority review	2019	Medicine addresses unmet medical need and provides major clinical advance	New chemical entities, new combination, new indication, new route of administration	Timing at request: 2–3 months prior to submission. Same standards for dossier Unmet medical need should be justified unless the drug or indication is under a special national scientific research and development program	Standard regulatory review: 360 days (15–18 months) Priority review: 240 days (10–12 months) Median time to approval (NAS) 2021: no data available	[43]
Taiwan	Abbreviated review Category I	2010	New chemical entities already approved by 2 of the 3 regulatory agencies (FDA-US, EC/EMA or MHLW/PMDA) with bridging study waiver	Initial MAA	Dossier to include the full assessment reports issued by the reference health authorities, the Risk Management Plan and the post-marketing commitment reports from the reference health authorities. BSE waiver (lead-time 6–9 months) and designation (lead time 1 month) need to be available before submission of the MAA	Standard regulatory review: 360 days Streamlined review: 180 days Median time to approval (NAS) 2021: no data available	[43]
United Kingdom^a,b	Rolling review	2021	All new active substances and biosimilars	Initial MAA	MAA is submitted in separate modules for starting a pre-assessment phase	Median time to approval (NAS) 2021: no data available	[71]
United States of America^a	Priority review program	1992	Drug products intended for a serious condition, expected to provide a significant improvement of efficacy/safety of the treatment, diagnosis or prevention	Initial NDA/BLA or efficacy supplement	Timing of request: at time of marketing authorization application FDA will inform the applicant within 60 days in case they decide to grant priority review	Standard regulatory review: 12 months for New molecular entity (NME) NDA and original BLA. 10 months for efficacy supplements Priority review: 8 months for a NME NDA and original BLA and. 6 months for an efficacy supplements Median time to approval (NAS) 2021: Expedited: 242 days Standard: 365 days	[15, 47]
United States of America^a	Fast track Program	1997	Drug products intended for treatment of serious or life-threatening disease or a condition with an unmet medical need		May be requested at the time of an IND or thereafter, ideally no later than pre-submission meeting. FDA accepts/denies within 60 calendar days of receiving the request Provides opportunity for: • Frequent interactions with FDA • Rolling review—requires submission of complete CTD modules • Potential for priority review Applicant must demonstrate that drug meets eligibility criteria and has potential to address unmet need based on non-clinical and early clinical data	Note: Fast track designation can be withdrawn if data no longer support drug potential	[47]
United States of America^a	Split Real Time Application Review (STAR)	2022	Applies to all therapeutic areas	Efficacy supplements for novel uses of existing therapies for patients with a serious condition with unmet medical needs	Part 1 can be submitted as early as 2 months before completing the application. Sponsor submits the efficacy supplement minus the final clinical study reports and clinical summaries	Although the review clock begins with submission of Part 2, FDA will set an action date to be at least 1 month earlier than the normal 6-month goal date for a priority review application	[72]

^aCountries participating in ORBIS: Participation can potentially shorten overall review time by collaborative review

^bCountries participating in ACCESS consortium. Participation in the ACCESS consortium can potentially shorten overall review time by work-sharing