Avoiding Regulatory shortfalls in the Submission Path

May 16, 2022 REGai

Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal & external stakeholders, co-ordination with cross functional teams like R&D, QA, clinical research, safety, manufacturing, supply chain, marketing, and so on. At every phase of development process, companies are responsible for the safety and efficacy of their drug for human use. This needs a continuous communication with health authorities byproviding documents / dossiers. This is the area where many of the bio-pharma, consumer healthcare, medical device manufacturers, R&D department, CROs and regulatory agencies face challenges. All companies need clear guidelines on when, how, and at which stage they have need regulatory submissions.

Electronic Common Technical Document (eCTD) was designed as per the ICH guidelines where it harmonizes the regulatory review process for global drug development. Even with sophisticated eCTD format and robust submission process with technology/tools, regulatory teams are falling short and getting rejections from the health authrities. According to FDA, duplicate submissions, mismatch between the application number in the us-regional.xml and the application number on the FDA form, wrong center choosing for submitting documents, missing the standard eCTD format while submission are the few reasons for getting rejections.

Submission Challenges

Even after taking much care, proper plannig, and eCTD submission tools – still there can be some challengeslike:

Country specific requirements : USA, EU, Japan, Australia, etc., different counties have their own defined regulation. Manufacturers need to be up-to-date with often changing global regulations which may affect submission requirements.

Data inconsistency : According to the information from FDA, most of the companies are failing in describing adequately about their product. Several subject matter experts may also author different sections of the submission, leading to an inconsistent storyline.

Absence of regulatory strategies: Strategies must be defined by manufacturers and conduct meetings with agencies on pre-submission guidance and clarity on needed data. Regulatory strategies must be premised on competitive landscape, on target market, on an unmet medical need, on to get opportunity for first-in-market, and on initial target indication.

Less experience on submission: Most of companies facing problems in recruiting and retaining subject matter experts to manage submissions. Also, changes in business strategies like expedition or new combination products are resulting in skill gaps for submission teams.

Along with these issues, several others like submission agenda fluctuations, collecting lot of scientific/medical material from different contributors, disconnected IT tools that are preventing end to end process oversight.

Some Tips To Save Time and avoid Risk in Submissions

Have you ever faced rejection or delay in submission of your regulatory documents? Did you go difficulty in compiling the documents into PDF before submission? No matter how big the company would be, phase of the product would be – there are professionals facing issues furthermore technical documentation is a challenging part. It involves numerous steps and potential opportunities for missteps. To overcome all those issues, do you need to speed up your submission process? Do you want to reduce the risk of compiling technical documents for submission? Tips here will help you to streamline the submission process.

Tip 1: Centralized PDF conversion

Visually and technically consistent PDFs are required for quick, smooth approvals of documents from regulatory authorities. It’s definitely a tough job when we are using multiple technologies for creating and modifying the documents. Moreover, various departments will be giving documents whenever they get new results; accordingly we need to change/update the document. Updating each result will give something or the other inconsistency particularly when different user configures their own result document.

To overcome such issues a good tool with automated software will support in solving someof these issues. The same software should also contain template/format that complies with specific regulatory body. Such PDF rendering software retrieves data from all dissimilar controlled content repositoriesinluding file shares, web services and email repositories. Once all the data pooled from various repositories, converting software will adjust files in consistent and compliant PDF format which is in ready to submit format to any global health authorities

Tip 2: Make compliance earlier than submission period

While making PDFs manually or by using online tools you typically face a problem of editing the documents in respect to meet the health authorities’ technical requirements. It’s really difficult to edit the content in between the text even if you use adobe editor or other editors. Moreover a regular PDF’s will not be compliant by default, for this reason everyone needs to have additional steps and needs to use additional tools to make the PDF compliant as per regulatory requirements. If not this strategy, one must wait until all the works/edits done in word document till the moment before submission time and convert it as PDF, then submit or allow publishing tool to make the necessary adjustments for submission. Practically it takes a lot of time, nevertheless technical issues will be discovered very late that prone to make more mistakes at the time of submission.

To overcome this, one must ensure the compliance at a very beginning of submission content preparation process. Automatic compliance should be achieved immediately when you render the document to PDF. This automatic compliance typically does not require any additional tools, or manual steps in conversion process. This helps to shift focus towards generating quality content, which further supports in reducing the number of issues being resolved after the publishing stage. So, do not wait till the last minute to make each and every single document into one PDF.

Tip 3: Automating PDF

Using automated PDF rendering system in an organization will enhance the efficiency of compliance for regulatory submission. Once documents get uploaded with content required for submission, systems can automatically render content into multiple versions of your PDFs that meet the respective health authority requirements. This system also supports in such a way by creating multiple versions upon new updates, by coloring hyperlinks, by bookmarking figures and tables, by adding table of contents upon exceeding the specified number of pages, by highlighting the extra content, and by optimizing for fast web viewing.

Bottom line issubmissions-ready PDF content is essential and possible with the inputs above for ensuring a quick as well as confident review by regulatory bodies.