On Tuesday mornings, one might expect to see new invitations for tenders in their inboxes.
Some respond because the product matches the tender specifications, the price is competitive, and the potential buyer is ready to sign.
Everything seems to be going to plan until the regulatory team asks the mother of all questions: Is the CTD dossier registered, or is it still in construction?
For the majority of generic medicine importers, the truthful response is given long after the opportunity has elapsed.
The submission window has closed, and no amount of price adjustment (or reduction) will be able to fill the CTD dossier in six weeks.
This is how failures of institutional pharma procurement begin to manifest. Tenders are not lost during the price per comparison stage.
Tenders are lost months in advance during the construction (or lack of) of a CTD dossier by an importer.
For importers, distributors, and regulatory affairs (RA) leads bidding for multi-million dollar, multi-year supply contracts, the CTD dossier construction is not a bureaucratic process.
It is the competitive differentiator. This article seeks to explain the reasons for the existing disconnect in timelines, the implications for buyers who are indifferent to it, and the extensively elaborated methods based on the ICH Common Technical Document.
It talks about the flexible reliance pathways and consistent CTD dossier investments, illuminating the path to continuous competitive advantage in tenders.
The Tender Opportunity – and the Clock That Governs It
While generic tenders do handle a lot of orders, the first thing they assess is if you’re eligible or not, not the price.
Whether you’re eligible or not is determined by your CTD dossier and your registration status.
Why tenders run the generic market
A good portion of worldwide generic drug sales occurs through state- and donor-funded procurement methods.
If we look at the generic drug market, we place it, very roughly, around USD 491.35 billion in 2024,[1] with the following years growing at around 5 to 9% yearly.
Documented procurement methods should concern buyers, as no single government or multilateral entity publishes a figure for the global market.
As such, available estimates should be interpreted as such, and the broad range of estimates should concern buyers.
What is documented is the eligibility gate. WHO Prequalification (PQ), the Global Fund, the PAHO Strategic Fund, and the UNICEF Supply Division.
The major pooled and donor-funded procurement mechanisms require that the procurement of a product be contingent upon registration, prequalification, and/or submission of a CTD dossier.
Registration is the eligibility gate
A product lacking a legitimate marketing authorization, PQ listing, or accepted CTD dossier will be excluded from a technical or price evaluation.
WHO Prequalification evaluates medicines against WHO standards, so UN agencies and national programs can buy with assurance
Some regional tenders now more commonly ask for submissions in CTD or ACTD format as a demonstration of manufacturing and quality assurance discipline.
It is a flawed assumption to think “we will register after we win”
Now that we understand why the CTD dossier locks tender eligibility, we will analyze the time constraints that are enforced after the publication of a tender.
The Timeline Mismatch at the Heart of Lost Tenders
Tender windows stretch to the weeks’ mark while CTD Dossier and registration work spans months to years. This is the highest reason for compliant, competitively priced products to fail.
The public procurement law does not accommodate a CTD Dossier.
According to the European Union public procurement rules, the minimum time limit for submission for a contract published by an open-procedure tender is 35 days.[2]
Tthis limit may be reduced to 30 days for fully electronic submissions, or 15 days where justified urgency is invoked.
Also, for World Bank International Competitive Bidding (ICB), the time allowed for preparation of bids for standard goods contracts is about six weeks.
While the tender windows are measured in weeks, the registration processes follow the opposite.
Many national marketing authorizations can take 1 to 3 years or longer.
For example, South Africa’s SAHPRA reported a median finalization time of 2,092 calendar days[3] for generic medicines processed through its erstwhile Medicine Control Council pathway (2011-2017), a figure the authority itself has subsequently worked to shorten through new review pathways.
The mismatch, at a glance:
| Phase | Average Time | Grounds / Reference |
| Submission Period for EU Open Tender | Around 35 days | EU Directive 2014/24/EU, Article 27 |
| World Bank ICB Preparation of Bids | Around 6 weeks | World Bank Procurement Framework |
| Preparation of a Comprehensive CTD Dossier | Several months to more than one year | Market Practice |
| National Marketing Authorization | 1 to 3 years or more | Observational Studies |
| MCC Median for SAHPRA (South Africa) | Approximately 2,092 days | SAHPRA / JPPP Data (2011-2017 Cohort) |
| Post-Reform SAHPRA Risk-Based Pathway | Around 68-73 days[4] | SAHPRA Pilot Studies (2021-2022) |
| WHO Collaborative Registration Procedure (CRP) for a Prequalified Product | 90 working days (suggested) | WHO CRP Recommendations |
As these sizes indicate, we as a company have provided the opportunity for commercial buyers to close the gap we have illustrated in the contract.
It is very clear from this table that a CTD dossier cannot be created or built within a tender window.
It must be previously created or built prior to the tender notice being published.
Having described the gap previously, let’s see what occurs commercially when buyers try to close the gap afterward.
What Scrambling for a Dossier Actually Costs
Late submissions of CTD dossiers not only cause delays in bids, but they also create actual avoidable technical failure points and commercially unquantified losses that are created in the process.
The Module 3 chokepoint
Quality/CMC (Module 3) specifications, stability data, impurity qualification, and process validation) is, by far, the most common source of regulator deficiency letters, and for good reason.
According to ICH quality (M4Q)[5] stability and impurity gaps during the process of submission will incite multiple rounds of requests for additional information and responses from the applicant, to the applicant’s inconvenience and significant delay.
The commercial loss
Budget readiness as protection of revenue, not as an administrative burden.
With an understanding of the cost of unreadiness, let’s identify the components of a “ready” CTD Dossier.
What a “Ready” CTD Dossier Actually Is
The ICH Common Technical Document (CTD) consists of five modules.
The electronic version, eCTD, is mandatory for the FDA and EMA and must be maintained throughout the product’s life cycle. It cannot be filed and forgotten.
ICH Common Technical Document (CTD) organizes marketing-authorization submissions in a five-module structure.
Its electronic version, eCTD (ICH M8), is compulsory for submissions to the US FDA and EMA.
Both agencies expect continued maintenance for lifecycle submissions (variations, renewals, and periodic safety updates).
The five CTD modules:
| Module | Content | Notes for Tender Readiness |
| Module 1 | Regional Administrative & Prescribing Information | Country-specific information; outside the harmonized CTD core; requires market-specific tailoring. |
| Module 2 | CTD Summaries & Overviews (Quality, Nonclinical, Clinical) | Serves as the entry point for the assessor; should accurately reflect the current status of the CTD dossier. |
| Module 3 | Quality Chemistry, Manufacturing & Controls (CMC) of Drug Substance & Product, Stability, and Controls | The largest and most complex module; the most common source of regulatory deficiencies and queries. |
| Module 4 | Nonclinical Study Reports | Often limited or waived for well-established generic molecules, depending on regulatory requirements. |
| Module 5 | Clinical Study Reports, including Bioequivalence | Bioequivalence data are essential for generic marketing authorization and are a critical component of the dossier. |
Modules 2-5 incorporate elements that bring a high degree of harmonization and reusability across markets.
The only module that has to be built from the ground up for each country is Module 1. Distinguishing that separation is what enables a multi-market CTD dossier strategy.
With the structure of the CTD dossier established, let’s explore the impact of readiness, expressed as the ability to submit a compliant dossier, on the speed of winning tenders.
How Dossier Readiness Wins Tenders
Maintaining a CTD core and having Module 1 documents pre-staged means that during tender time, it is an assembly job and not an authorship job.
Further, reliance pathways shorten the remaining national steps to only a matter of weeks.
The process is simple:
An importer who maintains Modules 2-5 to the full ICH standard and pre-stages country-specific Module 1 packages for each target market is referencing an existing CTD dossier when a tender is published and is not constructing one from a blank file.
Reliance and work-sharing principles then shorten the remaining steps for national registration.
The commercial implication is straightforward. If buyers invest in enhancing the quality of CTD dossiers before the announcement of a tender, they will have a structural advantage in being able to take advantage of the accelerated pathways when they are needed.
We have now addressed the mechanism; let’s look at the ways to build and maintain the underlying CTD Dossier Library.
Building and Maintaining a Master Dossier Library
CTD dossier readiness requires an ongoing commitment. Libraries are maintained and prioritized according to market and molecule.
Libraries are kept up to date through thorough lifecycle management.
Step 1: Prioritize markets and molecules
Focus on the markets and the molecules. Identify the tenders and the countries that are being sought, and look for the repeated molecules in them.
Build depth in the areas where the revenue is concentrated and do not try to be ready in all areas.
Step 2: Build the harmonized core once, to standard
To a standardized harmonized core, build Modules 2- 5 to full ICH CTD/eCTD specifications, quality summaries, a complete CTD Module 3 (CMC), and complete bioequivalence data.
This needs to be done so the technical core of the CTD Dossier is complete before the announcement of the tender.
Step 3: Pre-stage country-specific Module 1
Pre-stage country-specific Module 1. For each target market, Module 1 templates and administrative documents (application forms, labels, legal documents) will be created.
This guarantees that tender-time work is done in an assembly capacity, not in an authorship capacity.
Step 4: Lock and keep Module 3 current
Fix and maintain Module 3 as active. Keep specifications validated and up to date, maintain stability studies, and keep your impurity profiles current.
Module 3 is where the real test of readiness occurs. Treat Module 3 like a living section, not a frozen file.
Step 5: Maintain the lifecycle so the dossier never decays
Keep the lifecycle so that the CTD dossier remains in an active state. The variations, renewals, and updates should be performed promptly.
A CTD dossier that was compiled two years ago is not automatically considered compliant today unless the changes have been submitted and the data has been updated.
Step 6: Convert readiness into speed via reliance
Convert the readiness into speed by relying on the above factors. Aim for the WHO Prequalification when possible.
Utilize the Collaborative Registration Procedure and regional or continental means to gain fast national approvals from multiple tender markets with one strong CTD dossier.
Step 7: Keep a tender-response pack assembled
Keep a tender response pack ready. Produce a current bundle (dossier status, GMP certificate, CoA, CPP/COPP, commercial docs) so a bid can be submitted on time without a frantic dash to collect docs.
These 7 steps transform dossier work into an ongoing asset instead of something that has to be done from scratch and on the fly for each tender.
The buyers that understand this as an infrastructure and not just a documentation process will be the buyers that can respond to a tender on the same day it gets published.
Once we know how to construct the library, we can now analyze why the dossier is not the same document in all contexts.
The Regional Dossier Landscape: CTD, eCTD & ACTD
Dossier formats are not standard across the world.
Buyers who will be making exports across multiple regions will have to deal with structural conversions and not just simple translations within the formats.
Most markets will not accept the ICH CTD in the original form.
ASEAN uses its own version, the ASEAN Common Technical Dossier (ACTD), which is divided into four parts compared to the five modules of the ICH version.
This means that those exporting to ASEAN markets will have to do a substantial amount of work and restructure the ICH CTD into ACTD format before the submission deadline.
This is not just a simple reformatting that can be done in a short period of time.
Regional dossier and reliance landscape:
| Region / Market | Primary Dossier Format / Standard | Regulatory or Reliance Mechanism |
| USA / European Union (EU) | eCTD (ICH CTD) | FDA and EMA review; EU centralized procedure |
| Africa (Continental) | ICH CTD | African Medicines Agency (AMA) continental procedure; WHO Collaborative Registration Procedure (CRP) |
| ASEAN | ASEAN Common Technical Dossier (ACTD) (with some markets transitioning to ICH CTD) | ASEAN work-sharing and joint assessment mechanisms |
| Gulf Cooperation Council (GCC) | ICH CTD | GCC centralized registration |
| Latin America (Brazil / Mexico) | CTD-based dossier | ANVISA reliance pathways; COFEPRIS harmonization initiatives |
| WHO Prequalification (PQ) Markets | ICH CTD (WHO PQ dossier format) | WHO Collaborative Registration Procedure (CRP) |
Buyers doing business in several of these regions need a strategy that considers the ICH CTD as the reusable core.
Budgeting for format conversion, translation, and country-specific admin work needs to be done.
Having discussed the regions, let’s now see the manufacturing partnership strategy.
How Actiza’s Dossier-Ready Model Supports Importers
An importer’s bidding speed is only as fast as its manufacturing partner’s document preparation.
Thus, the importance of a manufacturing partnership is on the same level as the product.
An importer needs their partner to perform the tedious and slow preparatory work to be able to respond within the 35-day EU Tender period or the 6-week Tender period for the World Bank.
Partnering with someone who has WHO-GMP certification, CTD/eCTD ready Module 3, DMF/CEP with ongoing stability and quality data removes the biggest hurdle in the import process.
Actiza Pharma‘s commitment to regulatory diligence has led the company to establish a partnership for the manufacturing of finished products along with maintaining regulatory documentation.
As a result, the import and distribution partners do not have to wait for the technical portion of a Tender Dossier when Tender opportunities arise.
Check out finished formulations and certifications on the Actiza website for a deep dive into the details for manufacturing and compliance, or visit Actiza’s Tender and Export support contact page for inquiries regarding market-specific dossier readiness.
FAQ
Q1. What is a CTD dossier and why does it matter for tenders?
CTD stands for Common Technical Document; it is the standardized five-module structure by the ICH (International Conference on Harmonization) for the data on a product’s quality, safety, and efficacy for its marketing authorization.
It is important for tenders because for most of the institutional and donor procurements (for example, WHO PQ, Global Fund, and PAHO), a bid is unlikely to be evaluated on a price basis unless proof of registration or acceptance of a dossier is submitted.
Q2. How long does a CTD dossier take to prepare versus a tender deadline?
Preparing a complete CTD dossier takes several months (at a minimum) and often takes more than a year. Compared to that, the deadlines for tender submission are 35 days for Europe 6 weeks for other International World Bank Procurement activities.
Given this, CTD dossiers have to be built and maintained proactively because there is no feasible way to build one during an active tender process.
Q3. What is the difference between CTD, eCTD and ASEAN ACTD?
CTD is the ICH’s five-module paper/electronic dossier structure, and is used in the US, EU and most of the reliance markets. eCTD is the required electronic submission format of ICH M8, and is a CTD submission format required by both the FDA and EMA.
The ASEAN ACTD structure is a four-part dossier structure, and as such, requires a structural conversion of a CTD from the ICH, as opposed to a translation.
Q4. Why does Module 3 (Quality/CMC) cause the most delays?
This module provides the most detail about the product and substance specifications, as well as the evaluation of product and process validation, and of stability and impurity assessments.
This module is the most complex, and most likely to be critiqued, of the entire submission. Stability and impurity gaps most often lead to deficiency letters, and create the longest delays for the applicant due to the cyclical nature of queries and responses.
Q5. Does a “ready” dossier still need work for each country?
Yes. Modules 2 through 5, which contain the bulk of the technical information, will be the same for each country. However, Module 1, which includes the forms and letters specific to each country, must be completed for each target market. Reliance pathways, such as the WHO’s CRP, assist in the other modules, but do not eliminate the need for work in Module 1.
Conclusion
Tenders are generally decided before submissions are even due. This is based on the previous dossier work that has or has not been done in the months before the submission.
The difference in short tender windows and long registration timelines has created a structural and permanent gap, and will not fix itself. The only thing that can change the outcome is that the CTD dossier is treated as if it is permanent infrastructure.
This treats the core as if it is maintained, with modules for different countries already staged and reliance pathways, like the WHO CRP, being used.
For the importers and distributors that are building this type of infrastructure, the multiplier is in the discipline of the manufacturing partners’ dossiers.
You can check out the finished formulations and Regulatory Documentation support pages of Actiza, and/or get in touch with the tender and export support specialists of Actiza, who will provide you with the readiness assessment of your dossiers for the next target market.
- https://www.custommarketinsights.com/report/generic-drug-market/
- https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0024
- https://pmc.ncbi.nlm.nih.gov/articles/PMC9983237/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC9983237/
- https://database.ich.org/sites/default/files/M4Q_R1_Guideline.pdf
