FDA: Compliance | Regulations | DMF | Submission | Process | الامتثال: لوائح إدارة الغذاء والدواء الأمريكية | الملف الرئيسي للأدوية | تقديم | عملية

 

A Drug Master File (DMF) is a submission to the US Food and Drug Administration (FDA) that contains information about a specific aspect of a drug product, such as the manufacturing process, raw materials, or analytical methods. DMFs are used to provide confidential information to the FDA that is relevant to the safety and effectiveness of a drug product, but that the sponsor of the drug does not want to disclose publicly.

There are three types of DMFs:

Type I DMFs contain information about the facilities, processes, or articles used in the manufacturing, processing, packing, or holding of a drug product.

Type II DMFs contain information about the composition, manufacturing, and testing of drug substances (also known as active pharmaceutical ingredients or APIs).

Type III DMFs contain information about the stability of a drug product.

The steps in the Drug Master File (DMF) submission process are as follows:

Preparing a DMF submission: The sponsor of the drug (usually the manufacturer or developer) prepares a DMF submission that includes all of the required information and documentation. This may include details about the facilities, processes, or articles used in the manufacturing, processing, packing, or holding of the drug product, as well as information about the composition, manufacturing, and testing of drug substances (for Type II DMFs) or the stability of the drug product (for Type III DMFs).

Submitting a DMF to the FDA: The sponsor submits the DMF to the FDA through the Electronic Submission Gateway (ESG), along with a cover letter and any required fees.

FDA review of a DMF submission: The FDA reviews the DMF submission to ensure that it is complete and meets all regulatory requirements. If the FDA determines that the DMF is acceptable, it will be filed and made available to other parties (such as other manufacturers or developers) who may want to reference the information in their own submissions. If the FDA determines that the DMF is not acceptable, it will provide the sponsor with feedback on how to correct any deficiencies.

It is important to note that the DMF submission process can be a lengthy and complex process, and it is not uncommon for multiple rounds of review and revision to be required before a DMF is accepted by the FDA.

Maintenance of a DMF

To maintain a DMF, it is important to keep the information it contains up-to-date and accurate. This may involve regularly reviewing and updating the DMF to ensure that it accurately reflects the current state of the component, drug substance, drug product, or excipient. It may also involve submitting updates or amendments to the DMF to the FDA as needed.

In addition to maintaining the accuracy and completeness of the information in a DMF, it is also important to protect the confidentiality of the DMF. This may involve implementing appropriate security measures to prevent unauthorized access to the DMF and ensuring that only authorized personnel have access to the information it contains.

Overall, the maintenance of a DMF is an important part of ensuring the quality, safety, and efficacy of drug products and ensuring compliance with regulatory requirements.

There are several benefits to the DMF process for both manufacturers and regulatory authorities. 

Some of the key benefits of the DMF process include:

Access to information: DMFs provide manufacturers, importers, and other interested parties with access to information about the quality, safety, and efficacy of specific components, drug substances, drug products, or excipients used in the manufacture of drug products. This can help to ensure that these components meet appropriate standards and can be used safely and effectively in the manufacture of drug products.

Streamlined drug development: By submitting a DMF, manufacturers can provide regulatory authorities with information about specific components, drug substances, or excipients that can be referenced in the review of a new drug application (NDA). This can help to streamline the drug development process and reduce the need for additional testing or data submission.

Confidentiality: DMFs are confidential submissions to regulatory authorities and are protected from disclosure under the Freedom of Information Act (FOIA). This can help to protect the proprietary information of manufacturers and encourage the submission of high-quality, comprehensive DMFs.

Quality assurance: The DMF process helps to ensure the quality and consistency of drug products by providing regulatory authorities with information about the components, drug substances, or excipients used in their manufacture. This can help to ensure that drug products meet appropriate standards and are safe and effective for use.

Overall, the DMF process provides a number of benefits to manufacturers and regulatory authorities, helping to ensure the quality, safety, and efficacy of drug products and streamline the drug development process.

The drug master file (DMF) process can present several challenges for pharmaceutical companies. 

Some of the common challenges include:

Complexity of the process: The DMF process can be complex and time-consuming, requiring a detailed understanding of regulatory requirements and the submission process.

Resource constraints: Preparing a DMF requires a significant amount of time and resources, including personnel with specialized knowledge and expertise. This can be a challenge for smaller companies with limited resources.

Confidentiality concerns: DMFs contain confidential and proprietary information, which can make it difficult to share with regulatory agencies and other stakeholders.

Ensuring compliance: It is important to ensure that DMFs are complete, accurate, and compliant with regulatory requirements. This can be challenging, especially for companies with limited experience with the DMF process.

Changes to regulatory requirements: Regulatory requirements can change over time, which can impact the DMF submission process and require companies to update their DMFs to remain compliant.

Managing multiple DMFs: Companies that have multiple products may need to prepare and maintain multiple DMFs, which can be a logistical challenge.

Overall, the DMF process can be challenging for pharmaceutical companies, but it is an important part of the drug development process and ensures that the safety and effectiveness of the drug are thoroughly evaluated by regulatory agencies.

In conclusion, the drug master file (DMF) process plays a critical role in the drug development and approval process. DMFs provide regulatory agencies with information about the manufacturing, control, and distribution of drugs, helping to ensure that these products are safe and effective for use by the public. While the DMF process can be complex and challenging, it is an important step in ensuring the quality and safety of pharmaceutical products. Some of the potential benefits of the DMF process include providing regulatory agencies with important information about a drug, helping to facilitate the approval process, and providing transparency about the manufacturing and control of a drug. However, the DMF process can also present challenges, including the complexity of the process, resource constraints, confidentiality concerns, and the need to ensure compliance with regulatory requirements. Overall, the DMF process is an important part of the drug development process and helps to ensure that pharmaceutical products are safe and effective for use by the public.

Municipality: Dubai | Register | Import | Health products | كيفية: التسجيل | استيراد | المنتجات الصحية | بلدية دبي

 

In order to register and import health products in Dubai Municipality, suppliers must first obtain a valid trade license from the Department of Economic Development (DED). Once the license is obtained, suppliers must then register with the Dubai Municipality and obtain a health product registration certificate. This certificate is required for the import of health products into Dubai. Suppliers must then submit an application to the Dubai Municipality for the import of health products. The application must include the product details, test results, and other relevant documents. Once the application is approved, suppliers can then proceed with the import of health products into Dubai.

For import permit and shipment clearance, follow these steps:

Commercial shipments

1/Visit Dubai Municipality website – montaji.dm.gov.ae

 Register the company on the website

 Create Account

2/ Register the products (CPRE) for every item

 Login to account

 Go to services

 Select Consumer Products Registration ( CPRE )

 Fill the registration form with product details:

 Brand Name, Product Name, Barcode, Country of Origin,

Size... etc.

 Upload the required documents

 Pay the fees 10 AED / Product

CPRE-2020-XXXX will be issued for each product submitted for registration

3/ Step: Security Deposit (AED 15,000/=) to be paid through Deposits service (If required).

4/ Step: Import Request (CPIP)

 Login to account

 Go to services

 Select Consumer Products Import / Re-export ( CPIP )

 Fill the form with consignment Details

 Upload the documents (Bill of entry, invoice,

packing list, AWB, DO)

 Pay the fees 70 AED / Consignment

CPIP-2020-XXXX will be issued for each Consignment.

GMP: GLP | Compliance | Pharmaceutical Industry | أهمية الامتثال في صناعة المستحضرات الصيدلانية

 

 

The guidelines for food and medications in the United States, portrayed in Title 21 of the Code of Federal Regulations (CFR), are basic in guaranteeing protected and moral medication organization. Regardless of whether you are a scholastic organization, an administration office, or a drug organization, you need to hold fast to these standards at each progression of the medication advancement measure. Inability to do so could even course into a corporate closure over the long haul. 

Here is an overview of the fundamental parts of Regulatory Compliance for great assembling rehearses (GMP) and great lab rehearses (GLP) in GxP (great practice) labs and our way to deal with accomplishing and keeping up these principles. 

The U.S. Food and Drug Administration's (FDA; MD, USA) CFR Title 21 and the drug improvement measure. The FDA's Code of Federal Regulations Title (21 CFR) comprises of three parts enforceable by the three administering bodies – the FDA, the Drug Enforcement Administration (DEA; VA, USA) and the Office of National Drug Control Policy (ONDCP; DC, USA). The areas concerning drug advancement and assembling by and large fall into the main section. 

Here is a rundown of prominent parts with FDA 21 CFR Part 11, 58, 210, 211, and 820 giving standards and rules to the utilization of microplate per users and programming frameworks in directed conditions. 

Section 11 – Regulations on Electronic Records and Electronic Signatures: An especially basic segment, which ensures that electronic information is remained careful, dependable, and not controlled all through the medication advancement measures. 

Section 58 – Good Laboratory Practice for Nonclinical Laboratory Studies: Defines the administrative guidelines for nonclinical lab examines that help or are proposed to help applications for examination or showcasing grants for items managed by the Food and Drug Administration. Consistence with this part is planned to guarantee the quality and uprightness of wellbeing information to be documented. 

Section 210 – Current GMP, Manufacturing, Processing, Packing, or Holding of Drugs: Contains the base current great assembling practice for strategies to be utilized in the production, handling, pressing, or holding of a medication to guarantee that such medication meets the necessities of the go about as to security, and has the personality and strength and meets the quality and virtue attributes that it implies or is addressed to have. 

Section 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals: Provides the base current great assembling practice for readiness of medication items for organization to people or creatures. 

Section 820 – Quality System Regulation: Describes the necessities that administer the strategies utilized in, and the offices and controls utilized for, the plan, make, bundling, naming, stockpiling, establishment, and adjusting of all completed gadgets expected for human use. 

As should be obvious, CFR Title 21 is a broad rule that covers all parts of medication advancement and appropriation. Sub-atomic Devices (CA, USA) gives apparatuses and administrations identified with parts 11 and 58. 

How does FDA respond in the event of rebelliousness 
In a meeting with the Science Explorer, Timothy Bolus, Compliance Program Manager at Molecular Devices, communicates the significance of administrative consistence and how a pass in norms can have genuine results. 
Immediately, he portrays what occurs in instances of rebelliousness saw in a FDA review/assessment. 

FDA evaluators/examiners can show up unannounced. Throughout a review/assessment, there is abundant freedom to discover perceptions where certain practices over the span of business don't coordinate with composed prerequisites. These can grow into a conventional issuance of Form 483 toward the fruition of the review or investigation. This permits the organization a chance to perceive and alleviate the effect of their rebelliousness to their own standard working systems and quality guidelines. In the event that after a certain time span these perceptions go unsettled, the FDA can give Warning Letters, a conventional notice to the organization wherein the office refers to where the organization exhibited infringement to the guidelines. This can affect an organization's business activities, income, and in certain occasions, item reviews or corporate closures. 

GMP and GLP lab consistence arrangements from Molecular Devices 
To keep away from interruptions brought about by resistance, you need to expect likely issues and watch out for them in advance. Our main goal at Molecular Devices is to help our clients in accomplishing consistence in GLP (great research center practices) and GMP (great assembling practice) managed labs. For that reason, we have created demonstrated GxP consistence arrangements that go with our items. 
Demonstrated GxP answers for guarantee information uprightness and consistence. 

The assortment and respectability of information is maybe the most intricate part and consequently requires the most secure information obtaining and examination programming. That is the place where SoftMax® Pro GxP Software can assist you with accomplishing FDA 21 CFR Part 11 consistence. One of the features of the product is its framework review trail that tracks all progressions including date and time stamps, username, client ID, segment proclamations, signature data, and read results. This empowers you to see the clients who signed in, what they did, i.E., in the event that they erased, or changed information passages for control purposes. SoftMax Pro GxP Software likewise furnishes you with a controlled and exacting approval measure, which implies nobody outside the supported staff individuals can get to and use the framework. 

Another vital piece of research facility consistence is to guarantee that your framework produces dependable information without mistakes. That is the reason Molecular Devices offers the accompanying administrations: Installation capability (IQ), operational capability (OQ), preventive upkeep (PM), and fix inclusion. Our IQ/OQ/PM administrations guarantee that per users and washers are introduced and adjusted appropriately, and each progression of the capability is reported. This will likewise make the following of potential issues considerably more pragmatic. 

The approval administrations performed by Molecular Devices doesn't end after the underlying establishment. You can plan your own Performance Qualification (PQ) or User Acceptance test (UAT) to gauge the exhibition of your microplate per user by means of Spectra Test Validation Plates, which survey the precision and repeatability of absorbance, fluorescence, and glow highlights of your microplate per user.

 

Pharmaceutical Industry: Regulatory Affairs | India | دور الشؤون التنظيمية في صناعة الأدوية في الهند

The proposed reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of non-COVID vaccines while witnessing clinical trial. the Health Ministry's May 18, 2020, review announcement, saying it allowed manufacturing and stockpiling of COVID- 19 vaccine under clinical trial for marketing authorization for trade or distribution.

Because of this rule, it came possible for manufacturing and stockpiling the COVID- 19 vaccine during the clinical trial and they could make the vaccine available in such a short span of time to cover millions of lives.

By the end of 2020, SII( Vaccine Manufacturer) has formerly produced around 50 million tablets of the Oxford- AstraZeneca COVID- 19 vaccine" Covishield", indeed while it awaited the medicines Controller General of India'' s( DCGI) nod for exigency use of its vaccine in the country.

In view of the successful result of this provision for COVID- 19 vaccine, this provision should also be enforced fornon-COVID-19 vaccines, of authorization to use the remaining amounts of batches of COVID and non-COVID vaccines for marketable purpose which have been used in a clinical trial.

In this environment, the Health Ministry had issued draft rules dated April 12, 2018, to allow the remaining amounts of batches of vaccines which have been used in a clinical trial for marketable use after the entitlement of authorization in Form 46(now it's Form CT- 23) and manufacturing license in Form 28D. still, this draft rule has not been enforced till now. This draft rule should be enforced shortly to avoid destruction of life- saving vaccines.

Also perpetration of recommendations of inter-ministerial commission for reforming the medicine Regulatory Systems in India. The letter stated that on the directions of Prime Minister Narendra Modi, a high- powered inter-ministerial commission for reforming the medicine Regulatory Systems in India was constituted on May 11 last time under the chairmanship of also officer on special duty Rajesh Bhushan, who's presently the union health clerk. series of meetings of this commission was held starting May 2020.

Recommendations of this inter-ministerial commission should be enforced incontinently in line with the ease of doing business. Putting forward the following points with relation to necessary nonsupervisory reforms in the being Drug Regulatory system for your kind reference and intervention, which will take the vaccine assiduity of our country to new heights in the world.

The high minister's vision mentioning," It's a matter of great pride for all of us that because of our Prime Minister's vision about the nonsupervisory reforms, the vaccine assiduity of our country is growing veritably presto and under his global leadership, India has proved that as world leader in vaccine sector.

Pharmaceutical: Market | Marketing Authorization | جلب دواء جديد إلى السوق: أهمية ترخيص التسويق

When a patient includes a serious illness and there's no approved drug available, the physician might want to do one which has not been authorized for marketing by a national health authority but has shown promise in clinical trials. European Named Patient Programs, like US compassionate use programs, offer physicians access to pharmaceuticals which haven't yet been licensed. However, there's one important difference: in Europe an unlicensed drug may be reimbursed. This presents drug-makers with a chance to come up with revenues while development remains in-progress.

Significant Revenues Are Possible

The additional revenues are often considerable. as an example, Pharmion, a US based company that specialize in Oncology and Hematology reported dramatic increases in its Thalidomide sales from $1.9 million in 2Q '03 to $15.3 million in 2Q '04, primarily thanks to named patient sales in Europe for myeloma. Thalidomide sales accounted for about 75% of Pharmion's total revenues for the primary half 2004, company sources, and were generated while the merchandise awaits marketing approval for this indication. Before receiving European Marketing Approval, Shire's Argylin® for essential thrombocythemia generated about 5% of its total sales from its European named patient program.

Though thalidomide and Agrylin were licensed within the USA for a few indications, pharmaceutical companies do set-up named patient programs and receive full reimbursement for drugs that aren't licensed for any indication in any market. Examples include: Insmed's SomatoKine® authorized for named patient use for Primary Lateral Sclerosis, human growth hormone Insensitivity Syndrome (GHIS) and Severe Insulin Resistance and Protherics' ViperaTAb(TM) authorized for named patient use for adder snake bites.

Other Benefits of Named Patient Programs

A named patient program can speed uptake after official launch. Physicians, who have had experience before launch, via clinical trials or named patient programs, often become early adopters and references for other physicians once the drug is freely circulating.

Named patient programs, like US compassionate use programs, can increase good-will toward the corporate because they simplify the method of gaining access for patients in critical need. Smaller companies often can't afford the executive time and costs of shipping drugs round the world before launch. this may result in frustration and resentment towards an organization that several physicians will remember long after a drug is officially on the market. Creating a proper channel eliminates the unfortunate need of denying requests and risking ill-will later.

A named patient program should be considered a crucial a part of a pre-launch program. It increases awareness to a pharmaceutical's existence, creates excitement, generates good-will and speeds penetration of the merchandise after launch.





Frequent Communication is critical

If one amongst the objectives is to get revenues, putting in a named patient program is simply the start. so as to realize success, physicians have to remember of the merchandise and what they have to try to urge it. Typical methods of informing physicians, like sales rep visits and ads, might not be appropriate because a license is critical to plug a drug. While physicians are accustomed simply writing a prescription and being through with it, named patient programs require paperwork that some find tedious. Therefore, the corporate must create an appropriate communication plan and work closely with the targeted health profession to stay them informed and simplify the method.

 

Issues to contemplate

You have decided to form a named patient program a part of your pre-marketing plan, what now? Administration: does one "go it alone" or work with an organization that's experienced at administering named patient programs?

There are several experienced organizations that may assist your company by gaining approval, setting-up the program, doing administration and taking care of physical distribution. If your organization is well resourced and encompasses a pipeline of products that may require named patient programs, be worthwhile acquiring the expertise internally. However, if you've got few appropriate products or a stream-lined organization, it's probably best to think about outsourcing.

Communication: You've founded the program; how does one optimize it?

If you are doing not have an experienced European marketing group, a company that's familiar in sales and marketing of pharmaceuticals in Europe can facilitate your to maximize participation within the named patient program. A communication plan, if properly developed and implemented can increase product awareness, but communication concerning an unlicensed product must be done appropriately. 

This plan should make sure that your entire target group:

Is fully awake to the merchandise and therefore the program.

Knows what has to be done to require advantage of the program.

Has an advocate available to guide them through the method